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 sanitary measure was taken based on the Single Sample Fiscal Analysis Report No. 38.00 / 2010 issued by LACEN / PR, which found that inside the packaging of the NEONATAL PRODUCT OF TWO-WAY POLI-BRASINO there was no equipment for neonatal use, but for use in other age groups.
Causa
Suspension of distribution, commerce and use, throughout the national territory, as well as the collection of lot 200209a of the neonatal device of two-ways poli-brasino, imported by kdl comércio de produtos médico-hospitalares ltda, located at rua eduardo froner nº 850, parque cid. brasília, guarulhos - sp.
Acción
According to routine UTVIG / NUVIG / ANVISA, the company was asked to keep the UTVIG informed and updated of the progress of the batch process 200209A.
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 Baxter Hospitalar Ltda, as a result of a field correction performed in 2003 by the company, some hemodialysis equipment of the SPS 1550 model may contain electronic boards with wrong versions of software. The correct software versions for 1550 devices are 4.1B (for System 4 equipment) and 3.0A (for System 3 equipment). Software versions other than those listed above (on the side panel of the machine) display the incorrect "USE UF MANUAL" message when code errors FL04, FL07 and FL08 occur. Correct software versions (3.0A and 4.1B) display the message "DISCOUNT TX" (TX = Treatment) in the occurrence of these same error codes. The company has already sent a letter of communication and is making available the correct software update for its clients. #### Update: The action was closed by the company in December 2010, according to a letter sent to UTVIG (File: 009119 / 11-7 , 05/01/2011). According to Baxter, all customers (286) were notified and visited by company technicians for software upgrades.
Causa
The equipment may issue an incorrect instruction to the user, leading to continuation of hemodialysis therapy in situations in which it should be discontinued.
Acción
To health facilities: If you have this equipment at your health facility, proceed as follows: (1) Identify the software version of your equipment, following the manufacturer's instructions (see attachment); (2) If the software version of your equipment is different from versions 3.0A or 4.1B, instruct equipment operators to discontinue the treatment whenever the dialer side panel reports error codes FL04, FL07 or FL08, disregarding the UF MANUAL "instruction that will appear (this message is incorrect for the mentioned error codes). It is highly recommended that a written, easily identifiable work instruction be placed near the equipment panel that alerts operators to 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
Receipt of this information occurs because company records indicate that your organization has purchased internal paddles used in the LIFEPAK defibrillators / monitors listed above. If you no longer use these accessories, your organization is not affected. The company established a schedule of action until June / 2010 for the communication of its clients - letter attached to this Alert - July / 2010 for regularization of the petition with Anvisa and August / 2010 for the conclusion of the process. Anvisa is following this case.
Causa
Physio-control, inc., a division of medtronic, inc. has updated the sterilization guide for internal defibrillator / monitor blades: lifepak®9, lifepak 9p, lifepak 12, lifepak 20 or lifepak 20e by removing ethylene oxide from the method sterilization. recommended methods are sterrad® 100s equipment and pre-vac steam.
Acción
For organizations that use the internal defibrillator paddles listed above, the Sterilization Guide should be replaced for all of these accessories. We recommend that a copy of this notice be forwarded to the sterilization departments. Attached to this information is being provided the new sterilization guide (in Portuguese). The Physio-Control division is committed to ensuring that all customers are always assisted. Please contact technical support on 011-2182-9200 for any additional questions related to this action.
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
On May 3, 2010, the US Food and Drug Administration (FDA) ordered the Baxter company to perform the recall and destruction of Colleague Infusion Pump equipment currently in use in the United States. According to the FDA and Baxter, the imposition of the recall was not motivated by any risk attributed to the product. The reason for the payment was the company's failure to comply with the deadline to finalize corrective actions in the software of the equipment marketed in the United States. The FDA has not yet set the deadline for the recall and together with Baxter discusses the best strategy in order to minimize problems for patients and not affect their safety. Baxter is expected to submit a written plan to the FDA by the end of May 2010. Anvisa requested the product registration holder (Baxter Hospitalar Ltda, Baxter's Brazilian subsidiary) to provide information on the situation of Colleague pumps in Brazil. According to the company, imported Colleague pumps (about 5,700 units) received software updates that were not implemented in the US. According to the company, these fixes solve problems in the equipment. In the medium term, Baxter Hospitalar Ltda will replace the software version of Colleague pumps with a new version (see P.1.7). Version P.1.7 will be finalized by 2011 and, after Anvisa's approval, will be implemented in all equipment commercialized in Brazil. Anvisa is monitoring the developments of the case with Baxter Hospitalar Ltda and has not yet determined the collection of Colleague infusion pumps commercialized in the country. The implementation of the measures by the company is being checked (software replacement) To date, there are no notifications of adverse events or technical complaints involving the product in Brazil. The case is being accompanied by the Technovigilance Unit (UTVIG / NUVIG / ANVISA) and new information will be released as soon as it is available. #### UPDATE: The field correction was completed by the company on 10/30/2014. According to the company, 7,731 units were corrected (out of a total of 8,943 units) - of 1,212 uncorrected equipment, 1,083 were not located by the company and 129 had no external movement (movement without "low" termination in the company's system).
Causa
Equipment collection colleague infusion pumps determined by the food and drugs administration (fda), applicable only to the usa.
Acción
To date, there is no evidence that the use of Colleague infusion pumps (Baxter company) in Brazil has been interrupted.
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 Technovigilance Unit is following up on this case.
Causa
Envelope seal width of some product packaging is out of specification, which may compromise product sterility.
Acción
Johnson & Johnson Ltda has already begun collecting affected lots. If you have the affected product in stock and have not yet been contacted by Johnson & Johnson or any of its distributors, please segregate the product (identify it correctly so that it is not inadvertently used) and contact the company. If a patient has recently received the implantable article (under risk), it should be monitored.
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 information presented by Philips Medical Systems Ltd., after two years of continuous use mechanical wear caused by vibration and frequent disconnections may cause an intermittent electrical connection between the battery and the equipment. The power outage during the use of the equipment may cause it to restart with interruption of therapy (monitoring of the electrocardiogram / electric shock for defibrillation of the heart muscle). #### Update (20/06/2012): Philips Medical Systems Ltda informed the UTVIG about the completion of the field action. According to the company, the addendums to the instructions for use were sent to affected customers in Brazil.
Causa
Blinking electrical connection between the battery and the equipment, which may cause the defibrillator to fail.
Acción
The company sent an informative letter to customers, with an addendum to the instructions for use of the equipment (Notice of Application of the Instructions for Use of the Lithium Ion Battery M3538A). It is recommended that all affected batteries be replaced after two years of continuous service, or when the battery capacity calibration fails, whichever comes first. The details of the instructions should be verified in the Letter to Customers (available at http://portal.anvisa.gov.br/wps/wcm/connect/f13aa60042b4e27f8b89cbb134f70e0f/Carta+a++Clients.pdf?MOD=AJPERES) and in the Addendum to Instruction Manual (available at http://portal.anvisa.gov.br/wps/wcm/connect/3b74638042b4e3228b92cbb134f70e0f/Adding+to+Manual+of+Instructions+.pdf?MOD=AJPERES) .
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 received reports of problems associated with the two power supplies of the Lifepak 20 equipment (AC and DC power). AC power failures have been related to specific equipment failures due to network overload, preventing operation with AC power and battery charging. DC power failures have been attributed to waste from the solder flux underneath the component, which causes loss of current in the equipment. For further details, refer to the Field Safety Notice at http://portal.anvisa.gov.br/wps/wcm/connect/3913658042d9e5edba3bbb4817069f5c/Carta+ao+Cliente.pdf?MOD=AJPERES.#### Update ( 24/09/2012): The company informed that it is changing the scope of the field action (reduction of the number of units to be repaired) and that it intends to finalize the field action in Brazil within 6 to 9 months.
Causa
Possibility of failure of the power supply of the equipment.
Acción
The following actions are recommended to users of the product: (1) Verify that you have the Lifepak 20 equipment in your inventory; (2) Keep Lifepak 20 defibrillators / monitors operating normally, connected to AC power and keep DC power (continuous current - battery) in continuous charging whenever possible; (3) Follow the recommended daily steps in the Operator's Roadmap (Section 7, Appendix D) to check for possible AC or DC power failures before use; (4) If you identify power failures on some equipment, identify it and segregate it (substitute for another if possible) and contact the product registration holder in Brazil (Medtronic Comercial Ltda.) Or your representatives (Pro Life Medical Equipment and DMAV Medical Support).
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 manufacturer of the product (Smith & Nephew Inc. - Orthopedic Division) began a worldwide recall of the product, due to the problem mentioned. According to the company, the use of the product can lead to unnecessary damage to the tibial bone.
Causa
The markings on the tibial drill guide were made on the wrong side - the left side is printed on the right side and vice versa.
Acción
Users should follow the instructions: (1) Verify in their inventory the existence of affected products; (2) If you identify an affected product in your stock, immediately stop the distribution and use of it, segregate it and identify it to avoid accidental use; (3) Communicate the registration holder (form attached to the Letter to Users, available at http://portal.anvisa.gov.br/wps/wcm/connect/b9fe7b0042e01d3f81ed814817069f5c/Formul%C3%A1rio_Recolhimento.pdf?MOD=AJPERES ).
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 Biomerieux, the company decided to collect batches 73112 and 73113 from the Slidex Staph Kit as a result of a failure in the product release process: the aforementioned lots were released for commercialization in the national territory before the end of the analyzes carried out in the laboratory. quality control of the company. The Technovigilance Unit is following up on this case. #### The company informed UTVIG on 10/27/2010 about the completion of the field action, with collection of the affected units and the presentation of the certificate of destruction of the same.
Causa
Some batches of the product were marketed without the approval of the company's quality control area.
Acción
Users of the product should perform the following actions: (1) Verify in their inventory the presence of affected lots; (2) If a product is identified as being at risk, it must be segregated and the manufacturer informed. The company said it had already sent warning letters to its customers, stating the problem. The product is being collected from the market by Biomerieux.
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.
Notas adicionales en la data
Acción
Gambro's safety notice regarding the withdrawal and use of the oXiris 13B2803 series kits
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
It is not a question of withdrawal or discontinuation of use of the product. Anvisa is following the field action.
Causa
Based on customer reports, the following problems were identified in the implant, which will be treated with additional training and changes in implant practices: 1. reports of locking or gripping of the micro button were received during retraction of the protective sheath (where it is contained valve) of the delivery system by positioning the valve (pav) according to the instructions for use. to counteract this locking or adhesion, the maneuver was used to press the macro button up and continue to turn the micro button, successfully. 2. an account was reported describing an attempt to reposition the pav with a traction movement of the delivery system, which resulted in the exposure of the proximal pav loops, releasing it. it is not clear if the macro button has been locked to prevent movement of the pav out of the protective sheath. if the macro button is not locked and the clinician trains the delivery system, the capsule can be opened and the pav released. 3. reports of difficulty were released to release the proximal vas loops from the delivery system sheath, in the final stages of vap implantation. it should be noted that this is a safety alert, not involving recall or discontinuation of the use of the implant system.
Acción
Measures to be taken by the user: The risks when using the CoreValve® system remain low and acceptable; however, training and additional recommendations may lessen the implant problems described above. All users of the CoreValve® system will receive training so that they are aware of the new recommendations and instructions of the new Delivery System. This training will be given by a Medtronic representative (Chief / Implant Therapy Specialist or promoter) between August 11, 2010 and December 17, 2010. Before completing the training, the CoreValve® system can be used in accordance with current practices . In addition, customarily, no implant is performed without the accompaniment of a company professional.
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 registry holder's risk assessment, the problem may cause delay in treatment, thus exposing patients to risk.
Causa
Equipments can be very long and do not fit into the level 1 quick fluid heater, making the product unusable.
Acción
Health care facilities that use this type of product should review their inventory, segregate any affected units they own, and contact the distributor or the product registration holder. The company has already begun collecting the affected 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
Ethicon Endo-Surgery manufactures the trocates quoted in this alert as single-use products. In the case of customized kits, users should contact the assembler if they have questions about the products they have in stock. According to information presented by the registry holder, the recall was initiated because the manufacturer detected an increase in leakage reports on ENDOPATH XCELL products with OPTIVIEW technology, potentially potentially leading to loss of pneumoperitoneum during a surgical procedure. series of undesired consequences, such as drawbacks to users or the need to convert a laparoscopic surgery into open surgery. The Anvisa Technovigilance Unit (UTVIG / NUVIG / ANVISA) is monitoring this case.
Causa
Possibility of leakage on ethicon xcell products with optiview technology, which may cause loss of patient pneumoperitoneum during a surgical procedure.
Acción
Products under recall should not be used. Users of the product should take the following steps: (1) inspect your stock immediately and, if you locate an affected product, segregate it by identifying it so that it will not be used inadvertently; (2) Complete the Business Response Form and send to the registration holder (Johnson & Johnson Ltda.), By FAX: (11) 3030-1109, within 3 (three) business days, even if you did not locate the affected product in your inventory - mention Event 2244 in the form; (4) Keep a copy of the form in your records if you have any product to return; (5) To return the product, take a photocopy of the Commercial Response Form and place it in a box, along with the product - await contact of a Johnson & Johnson Ltda representative to ship the product; (6) Share this information with everyone involved with the product in your institution. Commercial Response Form: http://portal.anvisa.gov.br/wps/wcm/connect/fd170580448d8d7897fdd77d15359461/Formul%C3%A1rio+de+Components+Commercial.pdf?MOD=AJPERES
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 (Medtronic), the cause of the problem is the high contact power on the device's electronic circuit board. No patient injuries were observed by the company resulting from the problem in question. The company announces the closure of the field action with the following numbers: Number of clients informed: 67 - Number of units affected: 137 units affected, Number of units traded on customers: 98 units, Number of units in inventory (unlicensed): 12 units, Number of units not located on customers: 27 units. The 98 units exchanged on the customers and the 12 non-marketed units were re-exported to the factory.
Causa
Pacer may not turn on or off unexpectedly.
Acción
According to the product registration holder (Medtronic Commercial Ltda.), If there is loss of control of rate, performance, sensitivity, or power - non-low battery loss - the device must be disconnected and returned to Medtronic for repair or replacement. exchange.
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 product registration holder in Brazil, during the product implantation procedure there is a risk of foreign body embolization due to the release of the PGLA coating, which could lead to a stroke in the patient (in a more critical scenario) . PGLA is a bioactive polymer that covers the product's platinum spring and, according to Boston Scientific's risk assessment, the increased risk of its detachment (and consequent embolization) is limited to the surgical procedure. 05/2011): Boston Scientific do Brasil Ltda closed the field action on the Matrix product in January 2011, according to a letter sent to UTVIG (file: 083134 / 11-4). According to the company, 13 units of the product were collected in the Brazilian market, out of a total of 1429 units (0.9%).
Causa
Premature degradation of the pgla (polyglycolic-polylactic acid) suture, before expiration of the shelf-life of the product.
Acción
Recommended actions to professionals / users / patients of the product: (1) cease use of the product immediately; (2) Segregate the affected units, identifying them so that they are not used inadvertently; (3) Return the product to the record holder (Boston Scientific do Brasil Ltda); and (4) in the case of distributors, notify the customers who own the affected products. The company Boston Ltda has already started collecting the product.
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
Resolution RE No. 5,371, dated November 24, 2010, determining the suspension of the importation, distribution, trade and implantation, throughout the national territory, of all lots of the FEMALE CERAMIC ALUMINA ZIMMER HEAD product manufactured by ZIMMER INC., USA and imported by the company ARTHROTECH IMPORTAÇÃO EXPORTAÇÃO LTDA (CNPJ 02.348.439 / 0001-35), located at Av. Marechal Câmara, 350 Sala 901 - Centro, Rio de Janeiro - RJ, or by any other companies, for not having registered with this Agency .
Causa
Product not registered in anvisa.
Acción
Suspension of importation, distribution, trade and implantation, throughout the national territory, of all lots of the product HEAD FEMORAL CERAMIC ALUMINA ZIMMER.
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 EXaCT Targeting table is a complex mechanical device that can trap and injure the extremities of the human body, especially the fingers. Documentation already provided by Varian for this table includes warnings about these risks and instructions for safe use of the table. According to Varian, in the past mitigation measures have been taken.
Causa
Grooves on the tables can hold and injure parts of the operator's or patient's extremities, such as the fingers and toes.
Acción
Users of Exact Targeting should pay attention to the following instructions: Read and follow the recommendations and safety instructions in the user manual that came with the product, especially the chapter "Hazard and Safety Precautions" ). Maximum caution is advised when two people handle the table simultaneously. Patients should be advised to hold only the appropriate handles and guides on the table to avoid inserting their fingers into risky places. For detailed safety instructions, please read the Urgent Safety Notice posted by the manufacturer of the product at: http://portal.anvisa.gov.br/wps/wcm/connect/313eef8045112cd3ac7daeb34d2284eb/VarianSecurity Notice. pdf? MOD = AJPERES.
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 DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the under the Brazilian System of Conformity Assessment (SBAC). #### 06/30/2011 - The company Descarpack proceeded with the collection and destruction of the remaining products, object of this Sanitary Alert, proven by the Certificate of Co-processing # 02348/2011, issued by the company Environmental Engineering Momento, accompanied by the Municipal Visa of Ilhota / SC. The Authorization for Use of the Seal of Compliance has been reacquired as correspondence of the Falcão Bauer Institute of June 20, 2011. ####
Causa
Suspension of the authorization to use the seal of conformity identification motivated by the disapproval in the semi-annual maintenance test carried out by the falcão bauer institute of quality.
Acción
(1) Discontinuation of use and segregation of the product in stock. (2) forward to Anvisa (tecnovigilancia@anvisa.gov.br) the following information: batch / quantitative no. / Date of acquisition. (3) make contact with the record holder for possible recall.
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 DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the scope of the Brazilian Conformity Assessment System (SBAC). ##### UPDATE - 02/14/2011 - Regularization of the situation of the company next to the IFBQ, resuming the use of the Seal of Identification of Compliance referring to the GLOVE FOR NON-PULP SURGICAL PROCEDURE - (Registro Anvisa: 80105840003) - Maxter Glove - Malaysia, and can be marketed normally. Ref. 526/2011 - IFBQ. ##### UPDATE 04/04/2011 - Regularization of the situation of the company next to the IFBQ, resuming the use of the Conformity Identification Seal referring to the GLOVE FOR NON-PULP SURGICAL PROCEDURE PP Size - (Anvisa Record: 80105840003) - Supermax Glove - Malaysia, and can be marketed normally. Ref. 1000/2011 - IFBQ.
Causa
Suspension of the authorization for the use of the seal of conformity identification, made by the falcão bauer institute of quality.
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
See letter to the attached users - http://portal.anvisa.gov.br/wps/wcm/connect/b1475480495cd0d3b5c0f54ed75891ae/Alerta_1104_Customer_Response_Formular.pdf?MOD=AJPERES.#### Update (07/17/2012): the company presented inspection reports regarding technical visits to customers for product inspection. Alert closed.
Causa
Uncoupling the focus from your suspension arm, with the possibility of causing serious injury to patients or operators.
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
Notify by NOTIVISA (http://www.anvisa.gov.br/hotsite/notivisa/index.htm) for the commercialization of mask or respiratory protection equipment without registration or contact the Unit of Technovigilance (UTVIG / NUVIG / ANVISA) by email tecnovigilancia@anvisa.gov.br.
Causa
Use of masks and respiratory protective equipment not registered in anvisa and manufactured and marketed by companies without operation permit - afe.
Acción
The Technovigilance Unit alerts to the fact that if masks or respiratory protection equipment are used for the purpose of prevention in activities that imply exposure to respiratory risks, they are characterized as medical products and are therefore subject to registration with ANVISA, in accordance with Resolution RDC 185/2001. Thus, the acquisition and use of these products without registration in ANVISA constitutes a sanitary irregularity and its manufacture and commercialization represent sanitary infraction. The granting of registration of medical product is a prerogative of the National Agency of Sanitary Surveillance - ANVISA, and the company must prove, at the time of registration, its safety and efficacy according to the regulatory norms. The product registration number is on the label of the product. In case of doubts, consult the ANVISA website: (1). http://www7.anvisa.gov.br/datavisa/Authorization_Authorization/consulta_authorization_internet.asp; (2). http://www7.anvisa.gov.br/datavisa/Consulta_Produto_correlato/consulta_correlato.asp; (3). http://www7.anvisa.gov.br/datavisa/Consulta_Produto_correlato/consulta_correlato.asp; (4). http://www.anvisa.gov.br/scriptsweb/correlato/correlato_rotulagem.htm.
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 RDC 05, of February 15, 2008, the certification of gloves is a prerequisite for its commercialization. Anvisa is following the actions. #### 11/01/2011 - Anvisa published Resolution RE no. 94, of 10/01/2011, in the DOU no. 7 of 11/01/2011, prohibiting the importation and commercialization of the product. http://www.in.gov.br/servlet/INPDFViewer?jornal=1&pagina;=53&data;=11/01/2011&captchafield;=firistAccess.####14/09/2011 - OCP ICEPEX proceeds Certification for this model of glove, revoking the effects of this Sanitary Alert. #### 10/10/2011 - Anvisa revokes RE 94, through the publication of RE No. 4,528, of 10/6/2011. There is no restriction on the use of products from this company for lots manufactured after the date of certification.
Causa
Suspension of the inmetro conformity seal for failure to perform the extraordinary test in the hermeticity attribute as shown in the ela / l-202.184 / 10 and ela / l-202.775-10 mechanical test reports of this agency.
Acción
(1). Segregate affected products and send e-mail to tecnovigilância (tecnovigilancia@anvisa.gov.br) with the following information: batch number / quantity / date of acquisition. (2). Make contact with the record holder for possible collection of the product.
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
Abbott indicates that strips exposed to temperatures between 22 ° C and 30 ° C and / or extended storage times may be more susceptible to false result. It is possible to point out that up to the present time Abbott Diabetes Care Brazil had no reported complaints about falsely low blood glucose results, based on the reason for the American recall. Blood glucose monitors have not been affected and your users can continue to use their glucose meter normally. ANVISA follows this case. ###### SEE UPDATE ON ALERT 1044. #######
Causa
Affected test strips may provide falsely low blood glucose results, which may lead users to attempt to correct blood glucose unnecessarily and raise blood glucose levels due to a falsely low reading. the problem seems to be related to the application of the drop of blood in the test strip, requesting that it reapply blood more times than expected. this may occur regardless of the validity of the test strips, and / or if the test strips were stored at (or exposed to) high temperatures above 22 ° c and not exceed 30 ° c for an extended period of time.
Acción
Customers who hold test strips for affected lots should not continue to use the product. Abbott Diabetes Care will replace these affected test strips at no cost. Abbott Diabetes Care of the United States initiated this recall following an internal routine quality analysis which indicated that blood glucose test strips from certain batches of Precision Xtra, Precision Xceed Pro, MediSense Optium, OptiumEZ and ReliOn Ultima products may require reapplication more than expected, which can cause false readings of blood glucose. PLEASE OBSERVE THE APPEARANCE CAREFULLY IN ANNEX.
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
During August 2010, Medtronic received 45 (forty-five) reports involving the Model 3093 or 3889 - Interstim Stimulator Electrodes that ruptured during extraction and resulted in the retention of a fragment of the device in the patient's body . These 45 reports are part of an estimate of 4,482 electrodes extracted, totaling an occurrence rate of approximately 1%. Such an occurrence rate is based on voluntary and spontaneous reports and may be below the actual rate. Of these 45 reports, two reports were of residual pain and / or discomfort, one report of potential migration of the fragment and four reports of surgery for fragment extraction. The other reports did not include patient-specific outcome information. Anvisa is following this case.
Causa
Potential risk of rupture during extraction that may result in the fragment remaining in the patient's body.
Acción
Carefully read the annexes: Letter to the Client and Summary Information. http://en.wikipedia.org/w/index.php/ /Resumo_Informativo_FA_497_EN.pdf?MOD=AJPERES
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.
Notas adicionales en la data
Acción
Covidien safety note regarding the Quinton BETA-CAP adapter