Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
If the affected product is implanted in a patient, the manufacturer DOES NOT recommend removing the device. However, the final decision regarding this procedure should be at the discretion of the treating physician. ## UPDATE ON 9/1/2014 - COMPANY COMPLETED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##
Causa
Silicone catheters of particular batches were identified with a size less than 5.3fr than the size of 6.6fr mentioned on the labeling of the product. annex: letter to customers.
Acción
Company is conducting the renegotiation of affected lots. The lots REXC0931 and REXC0736 are under threat in Brazil. ## UPDATE ON 9/1/2014 - COMPANY CONCLUDED FIELD ACTION. THE PRODUCTS COLLECTED WERE DESTROYED, BY DECISION OF THE COMPANY, SINCE THAT 25 UNITS WERE REPATRIATED TO THE MANUFACTURER FOR ANALYSIS, RESEARCH AND POSTERIOR DESTRUCTION ##
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that this type of failure can be identified by the user before use. There are no health consequences that can have significant impacts on public health beyond immediate users. Still, there are no indirect health consequences as a result of the aforementioned event. If the GEN11 equipment is used, no quality deviation is expected. If the GEN04 generator is used, the manual activation of the device will not be observed before use.
Causa
The company has received customer reports describing that the xbb44b (bariatric video surgery product suite) product presents a discrepancy in etiquette and content. the johnson & johnson medical brazil nationalization label indicates that this kit contains the product code ace36e, however, it contains the product identified under code har36, which is duly registered with anvisa under no. 80145901455. the identification of the assembly ( xbb44b) and its configuration are not properly registered with anvisa. and the har36 code is not compatible with the gen04 generator.
Acción
The company directs you to: 1. Examine your inventory immediately to determine if you have the affected product that was manufactured by Ethicon and remove it. See Appendix A for assistance in identifying the affected product. 2. Complete the Commercial Response Form (Attachment B), send it to the fax: (011) 3030 1109 or e-mail: pcunha1@its.jnj.com. If you have a product to be returned, keep a copy of this form in your records. 3. All affected products must be returned by April 1, 2014. To return the affected product, make a copy of the completed form, place it in the box with the affected product, and contact us at (11) 3030 1289 (Patricia) or 3030 1032 (Juliana) for more details on the return procedure. 4. Even if you do not have the affected product in your inventory, please complete the fields on the business response form and send it to our company indicating that you do not have the affected products. 5. Please share this information with all the staff involved in your establishment. 6. If you need assistance identifying an alternate product code, please contact our Johnson & Johnson Medical sales representative directly.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Blue particles from the protective caps of the syringes may eventually come loose into the syringes. This occurs due to friction in the material when the protective cap is threaded during the syringe manufacturing process. The friction can cause wear and consequently, the particle generated in this friction can fall into the syringe. The cause identified for this quality deviation was a tool modification by the manufacturer of the product. The consequences may range from local redness to involvement of the microcirculation with blood vessel obstruction and phlebitis, as well as possible damage to organs such as the lungs, liver, kidneys and spleen due to the formation of granulomas. According to the registry holder in Brazil, no incident notification has been received so far. The actions have already been taken by the manufacturer and the problem has been eliminated in production. In order to avoid any risk to patients, the involved lots will be collected and destroyed.
Causa
It has been shown that blue particles from the protective caps of the syringes may eventually fall into the syringes.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Complaints have been received from clients in which they declare that the O2 sensor inside the ventilator is not working and that they need to move a patient from one ventilator to another surrogate mechanical ventilation. • If a sensor becomes nonfunctional during use and can not be recalibrated, an external oxygen monitoring device with oxygen alarm capability may be required to monitor the supplied oxygen level of the ventilator and provide the appropriate alarms. o A non-functional O2 sensor does not affect the oxygen concentration supplied by the fan and does not control the flow of gases. • If a sensor becomes non-functional and the institution's protocol requires the transfer of a patient to a surrogate ventilator, the patient should be clinically evaluated to determine the best transfer conditions to reduce patient risk. - According to information of the company the Field Action was completed.
Causa
Conflicting information was provided to puritan bennett 840 fan customers in an addendum to the label (p / n 066009a 09/02) stating that the oxygen sensor should be replaced every two years. the correct operational life is one year from the manufacturing date, as stated in the puritan bennett 840 fan operator's manual. the sensor, p / n 4-072214-00, must not be used after the expiration date printed on the oxygen sensor packaging. puritan bennett 700 series fan operator and service manuals also state that the oxygen sensor should be replaced every two years. the sensor, p / n g-062010-00, should not be used after the expiration date printed on the oxygen sensor package.
Acción
Company is submitting to its customers document with label update (Annex 2)
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UPDATE - 09/02/2014 - The company completed the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award report dated 08/20/2014.
Causa
According to the single sample tax report no. 3889.00 / 2013 issued by the adolfo lutz institute of the são paulo health secretariat, the equipment bureta la vita, lot klb5-120710a, was considered unsatisfactory in the test of appearance (foreign body presence).
Acción
Resolution No. 489 of 14 February 2014 determined the suspension of distribution, trade and use as well as the collection of the product BURETA LA VITA, lot KLB5- 120710A. ///// UPDATE - 02/09/2014 - The company finished the field action, the products collected were incinerated by the company SERQUIP - Waste Treatment Company, according to an award dated 08/20/2014.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
UPDATE - 02/24/2014 - The company informs that the recall action has begun and that customers and patients who identify the product must contact the company's SAC by telephone (81) 3538-0730 and e- mail sac.ne@descarpack.com.br //////// UPDATE - 07/13/2014 - The company sent the field action completion form. 800 units of the product were collected and incinerated.
Causa
According to the single sample tax report no. 113.245230, issued by the central laboratory of public health professor gonçalo moniz of the health department of the state of bahia, the product dischargeable equipment descarpack, lot nema035, was considered unsatisfactory in the aspect test ( presence of foreign body and the protective cover of the male connection being disconnected).
Acción
Resolution RE No. 493, of February 14, 2014, determined, as a sanitary measure, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product DISCHARGEABLE EQUIPMENT DESCARPACK, lot NEMA035
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The existence of excessive resistance of the connector in the lines providing the reference voltages to the potentiometers may cause a discrepancy between the actual physical positions and the respective position readings, which in turn leads to incorrect definitions, namely of the size of the field of treatment. As a result, the problem may cause a discrepancy between the actual physical positions and their position readings. Check full information in the company's alert message, available at: xxxx
Causa
Discrepancy between the actual physical positions and the respective position readings, leading to incorrect definitions.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
You can continue to use the MRx prior to inspection and installation of the upgrade hardware by your Philips Authorized Service Provider once you receive the notification: • Ensure that you are performing continuous inspections of the treatment connection on all MRx devices to detect the wear. The HeartStart MRx Instructions for Use, 453564396411 Issue 1, 453564307761 Issue 2, or 453564174011, a "Maintenance and Inspection of Treatment Connection When Using in Transportation" circulation, Addendum, Edition 6, describe how users can identify wear . • If wear is detected, immediately remove affected devices from use and contact Philips to program the service. After receiving the inspection and updating of the hardware (if applicable) from Philips, continue to perform continuous inspection of the treatment connection in accordance with the HeartStart MRx Instructions for Use to detect any wear in the future. WARNING: The life of the treatment cables / outer blades is up to 3 years. To maintain performance reliably and to reduce the possibility of failure during patient use, replace them every three years from the time they are used or if they fail to meet the criteria for inspection of the Instructions for Use. there is a potential that one or more of the following items may occur. • Delay in treatment • Incorrect energy distribution • Spontaneous / unintentional treatment energy discharge • Shock healthcare professional when administering treatment • Interruption of stimulation with loss of catch and inability to recapture.
Causa
When used in hospital or pre-hospital transport (emergency medical support), the connection between the pad therapy cable (including the cardiopulmonary resuscitation pad therapy cable, external pad cable and internal pad adapter cables / adapters ) and the inlet of the mrx connection may present high levels of stress, causing accelerated wear. connection wear can prevent the device from detecting that the blade handling cable is connected. this wear may also cause the mrx to inappropriately identify the handling handle for blades, outer blades, or inner blades. the wear of the treatment cable of the birds and the treatment connection inlet may present a risk to patients and / or health professionals.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
When monitoring through ECG electrodes, there is a potential for: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring You can continue to use the MRx before installing the update of the hardware being aware that if this problem occurs, you may experience the following symptoms: • Loss of stimulation demand mode • Inability to perform synchronized cardioversion with blades • Interruption of ECG monitoring or INOP messages If these problems occur, consult the HeartStart MRx Instructions for Use for troubleshooting assistance. In addition, the following measures can be taken: • If pacing demand mode is not available, fixed pacing mode can be used. Change the pacing mode to "fixed" in the pacing mode menu. • If synchronized cardioversion with the blades is not available, synchronized cardioversion with blades can be used. Switch to blades • If monitoring of ECG electrodes is not available, ECG monitoring via blades / blades is available. Plug the blade or paddle cable and push the branch selector button until the ECG waves from the blades or blades are displayed. • Connect a separate ECG trunk cable, if available. Important Note: Defibrillation, fixed pacing mode, paddle / paddle ECG monitoring, and other monitoring functions are not affected by this problem.
Causa
The connection of the ecg trunk cable and the locking of the mrx connector may be subject to accelerated wear, which may result in an uninterrupted ecg signal. interruption of the ecg signal may cause: • loss of stimulation demand mode • inability to perform synchronized cardioversion with the paddles • interruption of monitoring of ecg leads, which may delay appropriate treatment defibrillation, fixed pacing mode , paddle / paddle ecg monitoring, and other monitoring functions are not affected by this problem.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company advises that: As long as your customers are waiting to replace the power adapter of your device, they can continue to use the HeartStart XL. Use a backup defibrillator available to use if the affected HeartStart XL HeartStart XL did not deliver therapy. Access to the alert message: http://portal.anvisa.gov.br/wps/wcm/connect/f7d76c804316062dab25bfe6ad24d25c/Aviso+de+Seguran_FCO86100136.pdf?MOD=AJPERES
Causa
An internal component on the heartstart xl power board may malfunction and potentially affect the ability to deliver therapy. xl may be specifically unable to carry and deliver shock. in addition, when used for external stimulation, malfunction may result in a loss of capture.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the company's statement, if the Instructions for Use of the products are not followed correctly, improper use may lead to the impossibility of performing the surgical procedure (minimally invasive) and even cause the situation to evolve to death - with possible including during catheter rupture. Check Alert Messages posted by the company: WAITING FOR LINK UPDATE
Causa
Company safety notice regarding the correct use of the products.
Acción
The company is sending alert messages to its customers. In order to prevent further occurrences of adverse events / technical complaints with these products, the company is implementing corrective actions for technical improvement of the products.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that if the service identifies this problem, the VITROS ® System may have had a calibration failure or have presented lower than expected quality control results after the successful calibration of Lot 1590. If the control results are negatively biased, suspect that patient outcomes have been affected, consult your medical director in your laboratory to address any concerns you may have regarding the results of previously reported patients. The company informs that this is a situation in which the use or exposure to the affected product may cause temporary or clinically reversible adverse health consequences, or where the likelihood of a serious adverse health consequence is remote
Causa
The registrant reports that lower than expected quality control results have been observed using vitros ® total t4 reagent packs, lot 1590. results from the patient sample may also have been affected as the quality control results. there were reports of inability to calibrate by using vitros ® total t4 calibrators, lot 1590.
Acción
The company directs customers to immediately discontinue the use of all units in inventory of VITROS® Total T4 1590 batch and reagent pack. Lot 1590 should be discarded from inventory. The quality control results generated from Lot 1590 should be analyzed. If quality control results are negatively biased and patient results are suspected, the service should consult with your Medical Director in your laboratory to resolve any concerns you may have regarding the results of previously reported patients. Further information in a letter to the Client (Annex 2)
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
This problem can result in high patient and quality control results. The false control results and the patient's thyroglobulin may lead to an additional test. Based on the internal test, the observed increase in results ranged from 11% to 18% when the calibrators were reconstituted with 2.0 mL of distilled water and allowed to stand for 30 minutes prior to use. All levels of control and patient outcomes were affected. The percentage increase in response observed depends on the reconstitution time before use for the affected lots. A reconstitution time of 1 hour and 40 minutes or more using the affected batches provided appropriate recovery of control and patient outcomes. ///// UPDATE - 4/3/2014 - The company forwarded a response letter to all customers who received the aforementioned lots informing them of the necessary actions and forwarded an uncommitted lot. If any service still has lots quoted in this alert, please contact the company.
Causa
Beckman coulter of brazil received beckman coulter inc., an important product notice stating that the 30 minute reconstitution time is inadequate to fully reconstitute batches 324753, 325451, 327168 and 330203 of the access thyroglobulin calibrator.
Acción
The company directs customers to: i- Discard all Access Thyroglobulin Calibrator kits listed above. Determine when batches of calibrator number 324753, 325451, 327168, and 330203 were calibrated in your system and evaluate all results generated with the Access Thyroglobulin Calibrator to determine if the control and / or patient results were higher than expected or did not match the patient's clinical status. iii - Under the direction of the Laboratory Director, notify physicians that it is possible that the thyroglobulin sample results reported by your laboratory are affected by this problem.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Verify additional information with Terumo Medical do Brasil Ltda - Tel.:(11) 3594-3845 / FAX: (11) 3594-3802 / e-mail: ra@terumo.com.br.
Causa
Exposure of metal wire that gives "memory" to the cannula. exposed metal wire is usually detected prior to the procedure but, if not detected, its use may result in damage to cardiac tissue and a remote chance of air introduction into the cardiopulmonary bypass.
Acción
The registration holder is collecting the product in Brazil. If you own this product in your establishment, segregate it and contact the manufacturer / authorized dealer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Services that have units of these lots should contact the company to arrange for the collection.
Causa
Reprocessing in the aspect test of the product compressa surgical gaze hydrophila esteril herika, in accordance with the single sample analysis report 113.479 / 2013, issued by lacen ba, for lot 191012g11. presence of foreign body in inviolate packaging of lot 0155, as published in official gazette of the city of são paulo on 10/9/2013.
Acción
Resolution RE No. 4,937 of December 23, 2013 was published, determining, as a measure of health interest, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product COMPRESSA SURGICAL SURGERY OF GAZE HYDROPHILA ESTERIL HERIKA , lot 191012G11. The COVISA Communiqué 029/2013 was published in the Official Gazette of the City of São Paulo on October 9, 2013, determining the interdiction and collection of the product COMPRESSA SURGICAL GAZE HYDROPHILA ESTERIL HERIKA, lot 0155.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations for customers / users of the product, according to the company: "Keep the indicated batches segregated until collection and replacement by Injex, in order to no longer use a product that is in disagreement with your registration."
Causa
In the registration of the product with anvisa it is stated that the sterilization process used will be "cobalt-60 gamma radiation sterilization", however for these lots the "electron beam sterilization" process was used.
Acción
Collection and destruction by the company of the sterilized products in disagreement with its registration with ANVISA.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company informs that there is no impact on the health of the professional or the sterility of the processed devices. Still, it is very unlikely that this event will impact the use of the STERRAD® 100S sterilization system. ASP has already initiated corrective action to eliminate this defect in the manufactured product. • If the STERRAD® 100S sterilization system can not read the bar code, an error message may be displayed: "Can not accept cassette". • If the STERRAD® 100S sterilization system can read the bar code, the injection needles may align incorrectly or one of the following error messages may appear: "Injection Injection System (ISI)" or "Low Injection Pressure 1". In such situations, please read and follow the operating instructions for removing the STERRAD® 100S cassette. • If your STERRAD® 100S system experiences multiple cycle cancellations, it may be due to the damage of the injection needles, which may require a visit by the company's technical support.
Causa
The company holding the record informs that advanced sterilization products - asp has determined that 76 batches of the sterrad® 100s cassette may contain misaligned bar code and can be rejected by the sterrad® 100s sterilization system.
Acción
The company requests that customers evaluate the STERRAD® 100S cassette inventory to determine if they are part of the affected batches list below: • If your entire inventory is part of the affected batches list, ASP recommends that the customer continue to use them until it receives lots unaffected, as the probability of damage to the injection needles is low and there is no risk to the health of the professional or the sterility of the processed devices. Once the unaffected batches have been received, the customer may discontinue use of the batches and return them for replacement purposes. • If you have affected and unaffected batches of batches, the batches used should be discontinued and batches sent to the company for replacement. For more information, see Annex 2 - Customer Letter
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Informative note is necessary, since patients with allergic or hypersensitive substrate may suffer an allergic reaction. The company advises the users to always keep a good hygiene of the product and check with the patient if they usually have allergic reactions to products and to patients who, in case of problem, call the doctor / laboratory or technical support
Causa
The company holding the registration was informed through the product certification body (brtuv) that the equipment manual does not have information about the possibility of allergic reaction triggered by parts of the product when in contact with the patient. in view of this, the ocp suspended the p-622 certificate of the product until the company realizes the adequacy of the information.
Acción
The company that holds the registration in Brazil has made available on the company's website (https://www.cardios.com.br/noticias_detalhes.asp?IdNoticia=501&IdSecao;=11&IdTipoNoticia;=7) the product manual, in electronic format, with Information note about possible allergic reaction triggered by parts of the product when in contact with the patient. This Note will also be forwarded on physical media to users.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
According to the manufacturer of the product, under high concentrations of oxygen and pressure, there is a risk of spontaneous combustion of titanium alloys and other substances mentioned. Spontaneous combustion is related to some characteristics of these materials, together with the concentrations of ambient oxygen - titanium alloys IN CONTACT with an environment of high concentration of O2 (inside the chamber) can undergo a process of spontaneous combustion.
Causa
Hyperbaric systems, especially those pressurized with oxygen, should not be used in patients with external orthopedic fixators built in titanium and in composite materials, such as carbon fiber and fiber, for the risk of potential fire.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The semi-annual maintenance tests indicated that the sample analyzed does not meet the microbiological requirements of INMETRO Ordinance no. 322 of June 26, 2012. The health services that have the product in stock must segregate the samples so that the registry holder can proceed with the collection. ////// UPDATE - 04/17/2014 - The company informs that considering that gloves tested are Gloves for Non-Surgical Procedures, and that, due to their own instructions for use, Gloves for Non-Surgical Procedures Descarpack are not used in invasive procedures where controlled microbiological requirements are paramount. According to the American Pharmacopoeia, USP, non-sterile products are used in regions of the human body that are rich in bacterial flora and have physical or immunological barriers to infection. Examples cited are the oral cavity, skin, nasopharynx, rectum among others, which harbor a high and diversified viable microbial population. Recent studies carried out from the Human Microbiome Project underline the enormous size and diversity of human-associated bacterial populations. A healthy adult has a bacterial population of approximately 1014 bacteria, a number that exceeds the subject's own cells by a factor of 10. In addition, according to the results of test reports MIC-L-241861/1/14 (test) and 244561/1/14 (counter-proof) issued by the Instituto Falcão Bauer da Qualidade (IFBQ), pathogenic microorganisms were not found in the gloves. ///// UPDATE - 08/13/2014 - The company sent a report of completion of the field action, all customers were informed of the action of collection, and collected 135,388 cartridges of the lots involved in this field action.) / /// UPDATE 10/20/2014 - The IFBQ revoked the suspension of the Authorization for the use of the Conformity Identification Seal, in order to carry out all necessary actions and approval in the tests provided for in the Conformity Assessment Regulations, carried out in samples produced after corrective actions.
Causa
Suspension of the authorization for the use of the identification seal by the product certification body (ocp) for failure to perform the bi-annual maintenance tests in the microbiological attribute, according to reports micl / l-241861/1/14, mic / l-244561/1/14, mic / l-244561/2/14, mic / l-244585/1/14, mic / l-244760/1/2/14, issued by the ocp.
Acción
Company shall trigger a Field Action for the collection of the product, from the date of the last analysis of maintenance of the certification, occurred on 01/04/2013. All batches manufactured from this date must be collected from the market. /////// UPDATE 04/17/2014 - The company sent a copy of the letter sent to the distributors informing about the field action and the list of the lots imported in the period and that are the target of this collection (see ANNEX I) ./ //// UPDATE 10/20/2014 - The IFBQ, certifying body, issued document Ref.1563 / 2014 notifying the revocation of the suspension of the Authorization to use the Conformity Identification Seal.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company reports that to date, there are no reports of customers reporting product complaints or adverse events related to this problem. According to the risk analysis of the manufacturer, in relation to the deviation found, it is unlikely that an adverse health consequence will occur.
Causa
The company holding the registration informs that the manufacturer has identified that some units of the texturized gel mammary implants product manufactured between 2002 and 2010 were identified with an incorrect expiration date and distributed to some countries between 2006 and 2010, in addition to the date of expiration. this deviation was detected after reviewing the quality data in december 2013.
Acción
The company asks physicians who have used the product to verify the period of coverage of this field action, as well as the product code, serial number and lot involved (Appendix I - Customer Letter). The company also recommends that the physician monitor patients according to standard protocols. If there is any medical doubt, the professional should contact the local representatives for the best assistance.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company reports that false negative nitrite results may lead to an error in the etiology of Urinary Tract Infection (UTI). The problem would lead to a misunderstanding in the initial results of the urinalysis, with delay in obtaining the correct diagnosis between 12-24 hours and, in the worst cases, 24-48 hours (time taken to obtain the final results of the urine culture and tests of sensitivity). In the latter case, if there is an unrecognized UTI infection by Proteus that is resistant to conventional treatments, considered inadequate and / or inappropriate, the patient's condition may progress from worsening UTI to prioelonephritis, from pyelonephritis to sepsis, septic shock , stone formation in the kidney, renal failure and renal abscess formation. In diabetic and immunosuppressed / HIV patients, there is also the risk of emphysematous pyelonephritis, with the introduction of air in the kidneys resulting in permanent damage to the kidney in case of recovery. In pregnancy, there is also fetal risk or death./// Update on 05/26/2014 - The company informed that the collection action was completed and that all customers contacted informed that they did not have the product in stock.
Causa
A portion of the ichem velocity urine chemical strips from lot 7204051b (bottles number 16113 to 17000) was fabricated with an incorrect nitrite reaction area, which could generate false-negative nitrite results. of a total of 6,688 bottles manufactured from this batch, after investigation of the manufacturer it was detected that only 887 fr. (13.4%) presented the problem.
Acción
The company directs: • Inspect all remaining units in stock from Lot 7204051B to check if it has bottles numbered 16113 through 17000. • Discontinue use of the affected bottles and dispose of all remaining product in accordance with the procedures. • Replace the product with customers. • To the laboratories that used the affected flasks, reassess the samples previously tested. • Patients with signs and symptoms of Urinary Tract Infection (UTI) who have any of the test results below and negative nitrite results should repeat the test with another batch of strips: i) Urinary Chemistry: Positive Leucocyte Esterase, Negative Nitrite; ii) Urinary Microscopy: White Blood Cells Positive, Negative Nitrite. For more information, check the attachments I - Customer Letter and II - Distribution Map or contact the company by email: tof.comercial@ig.com.br
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The occurrence of the problem is extremely rare, due to the 50-millisecond time window in which both actions must occur: the detection by the instrument of a disconnection and the termination of an oxygen enrichment (O2) procedure in the gas mixture which follows for the patient. If the error is not detected by the operator after the patient's aspiration maneuver and PEEP is set to a lower value of 4 mbar, patient hypoxia may occur, putting your life at risk. Although it is very difficult to happen, in the occurrence of the error, the patient may be put at risk. However, the corrective action that deactivates the function of the automatic suctioning maneuver is very simple and quick to execute, as well as verifying that the deactivation has taken place. Immediate action required of fan users: as soon as the suctioning maneuver is completed, the user must make sure that ventilation continues. If ventilation is interrupted, one of the following options can be used to restore ventilation: 1- Press the "Manual Breathing" button on the front panel of the ventilator, 2- Toggle the Ventilation Mode or 3- Activate the standby mode ( "Standby") and return to the previously set Ventilation Mode.
Causa
Investigations have shown that ventilation and alarms of the hamilton-g5 pulmonary ventilator can be accidentally suppressed following the activation of a suctioning maneuver by the operator under a series of very specific circumstances. the ventilation should then be manually reactivated. the main cause, a synchronization problem of two program tasks processed simultaneously can result in fatal hypoxia in the patient.
Acción
Field Correction (Deactivation of function that may cause the problem).
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The semi-annual maintenance tests indicated that the sample analyzed does not meet the "microbiological" and "orifice verification - impermeability" requirements of INMETRO Ordinance nº332, of June 26, 2012. The health services that have the product in stock should segregate the samples for the record holder to proceed with the collection.////// UPDATE ON 05/29/2014 - The company informs that all the clients have been informed about the collection by means of letter and email and that they are still waiting the return of the answers on the quantity in stock.
Causa
Suspension of the authorization for the use of the identification seal by the product certification body (ocp) due to failure in the bi-annual maintenance tests, according to reports micl / l-241861/1/14, mic in accordance with the present invention, and in the requirement of orifice checking - impermeability, according to the report of test laamh nº000.147 / 14, issued by the ocp.
Acción
Company shall initiate Field Action for the collection of products manufactured from 01/04/2013. All batches manufactured from this date must be collected from the market.