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  • Dispositivo 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Alerta De Seguridad para CATHETER VENOUS CENTRAL MULTI LUMENS - Registered in Anvisa under the nu...
  • Tipo de evento
    Safety alert
  • ID del evento
    1090
  • Fecha
    2011-09-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 collected parts will remain segregated until Arrow International, a foreign manufacturer responsible for the product, sends the final conclusion investigation report and the process is properly completed, when other measures may be taken as necessary. Due to the traceability in the company's Customer Service (SAC), only 03 complaints regarding this lot number were registered. Gabmed provided training to these Hospitals on the correct insertion technique and on reading the instructions for use of the product. Anvisa is following this field action.
  • Causa
    Gabmed identified problems with the guidewire of the catheter, such as winding and bending, making progression difficult. the manufacturer is conducting root cause analysis.
  • Acción
    A statement issued to its customers, the company determines the inventory of said lot of the product for collection; if they still have pieces of the aforementioned in their stock, Gabmed Produtos Específicos Ltda will arrange the replacement for products of the same line but with another batch number. In case of doubts, get in touch with Nurse Pearl phone: (011) 5181-2224 email: sgq@gabmed.com.br.
Alerta De Seguridad para SURGICAL GLOVE SANRO LIS - registered under the number 10170480014 - Lot...
  • Tipo de evento
    Safety alert
  • ID del evento
    1091
  • Fecha
    2011-09-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 (SBAC). ### UPDATE - 01/14/2012 - The Certification Body communicates that corrective actions have been satisfactory, granting new Authorship for Use of the Conformity Identification Seal.
  • Causa
    Reproducibility in the mechanical test, attribute traction original, according to norm nbr 13391/95.
  • Acción
    Products related to the batch / models described should be collected, segregated and destroyed by the registry holder.
Alerta De Seguridad para VITROS IMMUNODIAGNOSTIC REAGENT KIT FOR B hCG TOTAL II - Registered in A...
  • Tipo de evento
    Safety alert
  • ID del evento
    1092
  • Fecha
    2011-09-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Ortho Clinical Diagnostics (OCD) has received complaints of observed results from diluted samples that were reported as <2.39 mIU / mL (IU / L) instead of No Result, which would be correct, and being accompanied by an Invalid Dilution - ID (Invalid Dilution). Action plan to be executed by the company (with schedule): - Register this notification in the database system for correct traceability of the case - Action taken on August 26, 2011 - Check which customers received the affected products and batches - Action held on August 26, 2011. - Communicate clients about what happened and guide the actions to be taken - Action started on September 9, 2011. - Obtain from the client the confirmation of receipt of the communication and actions taken. The letter signed by the client confirming receipt of the notification must be returned to the company by September 23, 2011. There are no records of notifications for this problem in Brazil, to date. Anvisa is following this action.
  • Causa
    Software failure that may affect the results of both the diluted samples manually and the samples diluted in the vitros eci / eciq immunodiagnostic system using the automated dilution feature and tested with the vitros immunodiagnostic reagent kits for β-hcg total ii, lots 0484 and 0530.
  • Acción
    The following actions are required: Before reporting your lab results, review all results of the VITROS product for β-hCG Total II generated from samples that have been diluted and tested on the VITROS ECi / ECiQ System. Dilution results should be compared with pure (undiluted) results to identify discrepancies when using Batches 0484 and 0530. Place the VITROS Results Analysis Procedure for β-hCG Total II, next to the VITROS System ECi / ECiQ, to warn operators about this failure and assist them in reviewing the results of diluted samples. You should consult your Laboratory Medical Officer and requesting physician to resolve any questions you may have regarding previously reported results, including Batches 0484 and 0530 of the VITROS Reagent Kits for β-hCG Total II. Contact OCD Customer Technical Services to report adverse events that may be identified. Fill out and return to the record holder the Confirmation of Receipt form.
Alerta De Seguridad para SYSTEM OF PLANNING FOR ECLIPSE eMC RADIOTHERAPY - VERSION 6.5 A 8.9. Reg...
  • Tipo de evento
    Safety alert
  • ID del evento
    1093
  • Fecha
    2011-09-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 the Urgent Security Notice issued by Varian, available at http://migre.me/5LjBo.
  • Causa
    Configuring the eclipse emc algorithm, with non-equidistant data points in the open field profile, can lead to incorrect results. the problem may lead to an incorrect dose release in the lateral direction.
  • Acción
    Varian has already started communicating the problem to all customers involved, according to a letter sent to UTVIG / ANVISA. If you are a user of the equipment in question, access the recommendations to users at http://migre.me/5LjBo.
Alerta De Seguridad para LifeCare Plum A + Infusion Pump / ANVISA Registration # 80253310023
  • Tipo de evento
    Safety alert
  • ID del evento
    1248
  • Fecha
    2013-05-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    The root cause of the problem is the undersized diaphragm (out of specification) manufactured by the component supplier. Both N250 and N100 events emit a visual and audible alarm to the user, which may occur during programming, use or performance testing (PVT) of the pump. Error codes N250 or N100 may cause delay or interruption of the infusion. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. Delay or interruption of therapy, in the worst case, can cause a serious injury or serious adverse events. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for use of an alternative pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. If any of these alarms appear, remove the cassette and reload it into the pump as described in the pump operation manual. If the recharge of the cassette fails to clear the alarm, replace the cassette and restart therapy. If the error persists, the pump has the diaphragm out of specification. Remove the pump from use and contact Hospira to report the event and schedule a review and repair (if necessary) of the pump. Access to the letter, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/89317a804f861883b3d1f79a71dcc661/1+-+FA212-04_Carta+Clientes.pdf?MOD=AJPERES UPDATE: 12/01/2014 - up to the present moment, has been satisfactorily fulfilling the field actions related to the cited product, as proposed in the action plan. It should also be noted that according to the reports sent to this ANVISA the company has already updated 4,847 units, which represents 79% of the installed plant in Brazil (total of 6,129 pumps). #### UPDATED ON 08/23/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time. #### UPDATED ON 08/23/2017, the field action documents sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    Possibility of the fluid detector diaphragm, located on the plum a + infusion pump, be out of specification and cause error code n250 "pump open during pumping" or n100 "not recognized cassette".
  • Acción
    Send letters to clients (hospitals and distributors). Identification and repair of all infusion pumps Plum A +
Alerta De Seguridad para GLOVE FOR NON-SURGICAL PROCEDURE WITHOUT POWDER LAGROTTA AZZURRA - Regis...
  • Tipo de evento
    Safety alert
  • ID del evento
    1094
  • Fecha
    2011-09-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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. INMETRO, through its Ordinance 233/2008, establishes the directives for such certification. #### UPDATE - 08/20/2012 - The Certifying Body - Institute for Certification for Excellence in Compliance - ICEPEX, communicates through the dossier (NP / ICEPEX-I 12246/2011 and NP / ICEPEX-I 12704 / 2011-1), which may be marketed. ###
  • Causa
    Periodic certification maintenance tests were not performed.
  • Acción
    All the products mentioned herein must be identified and segregated by professionals and services and maintained contact with the registry holder for collection and subsequent destruction.
Alerta De Seguridad para SLEEVE FOR NON-SURGICAL PROCEDURE NUGARD - Registered at Anvisa under nu...
  • Tipo de evento
    Safety alert
  • ID del evento
    1095
  • Fecha
    2011-09-29
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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. INMETRO, through its Ordinance 233/2008, establishes the directives for such certification. #### 10/28/2011: UPDATE - The Product Certification Body - IFBQ, clarified that not all lots of gloves of the model failed are subject to collection, with only those listed in the Annex remaining. #### 05/12/2011: UPDATE - The Product Certification Body - Instituto Falcão Bauer da Qualidade (IFBQ) - informed the UTVIG that it revoked the suspension of the authorization for use of the seal of conformity identification for the target product of this alert (GLOVE FOR NIR SURGICAL PROCEDURE). The company has collected and destroyed the nonconforming products collected, according to documentation submitted by IFBQ and the company to UTVIG. Alert ended.
  • Causa
    Failure in the annual maintenance tests, in the original traction attribute.
  • Acción
    All the products mentioned herein must be identified and segregated by professionals and services and maintained contact with the registry holder for collection and subsequent destruction.
Alerta De Seguridad para Male condoms "H" - registration 80325300002 - Lots: PM1005; PM1305 and P...
  • Tipo de evento
    Safety alert
  • ID del evento
    1096
  • Fecha
    2011-10-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 62 of September 3, 2008, male condoms for natural rubber latex must also meet the requirements for certification of compliance under the Brazilian System for Conformity Assessment (SBAC). #### UPDATE - 07/11/2011 - The affected lots included in this alert have been incinerated, according to Attached Certificate, in accordance with current legislation. The company will undergo a new inspection and testing for Certification. ####
  • Causa
    Failure in the counter-test tests as evidenced by test reports no. 212.151 / 1/2/3/11, in the possession of the certifying body.
  • Acción
    Check for the existence of the affected product in your inventories and segregate them for recall from the manufacturer, record holder.
Alerta De Seguridad para VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Pr...
  • Tipo de evento
    Safety alert
  • ID del evento
    1097
  • Fecha
    2011-10-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 received by the UTVIG, there are 25 units potentially affected by the problem in Brazil. In its risk assessment for the case, the company has presented some potential hazards and damages that may result from nonconforming installations: loss of video signal, non-operation of the failure latches and overheating of light cranks (which may system components, such as flexible arms, surgical lights, flat panels, etc.). According to the company, the probability of occurrence of such events is remote and no related adverse events have been reported to the company so far. #### UPDATE - 10/01/2012 - The company forwarded file 0037019 / 12-3 , where he reports the completion of the field action, and all clients were informed. ####
  • Causa
    Documentation regarding product installations is incomplete or inadequate.
  • Acción
    Stryker do Brasil Ltda reported that it has already begun to communicate to customers who own the equipment. Health care facilities that have affected equipment should schedule an inspection with Stryker, to verify the situation of the equipment installed and to prepare appropriate documentation.
Alerta De Seguridad para CONTOUR TS Blood Glucose Test Strip - BAYER - Record 80384380008. CONTOU...
  • Tipo de evento
    Safety alert
  • ID del evento
    1098
  • Fecha
    2011-10-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Bayer states that it conducted extensive testing (described in the health risk assessment, modeling data and sensitivity analyzes) and determined that the problem potentially affects 25- and 10-strip flasks, but does not affect flasks with 50 units. It points out that, as documented in the health risk assessment, modeling data with sensitivity analyzes, and external expert review, Bayer is confident that the potential downward deviation of these products does not endanger the health of users. Bayer is evaluating corrective measures to definitively resolve the deviation issue down. As a consequence of the acquisition of Schering do Brasil, as well as the transfer of the records of the products to Bayer S / A, it informs the imported lots affected. Anvisa accompanies this action. #### UPDATE: 04/09/2012 - The company presents a validation report of the new packaging of reagent strips, which constitutes a permanent corrective measure for the problem indicated, through dossier 0714259 / 12-5. ####
  • Causa
    The company has identified that under certain conditions, certain test strips of the vials containing 5.10 or 25 units may operate outside the specified parameters and produce downward deviation reading during the blood glucose test.
  • Acción
    As of September 22, 2011, to ensure the continuity of the supply of the Bayer product to consumers in Brazil, the Contour TS product (Test Kits and Strips) is being exchanged for the product Breeze 2 (Kits and Test Strip Disc ) that is not affected by the downward deviation problem. Consumers who have questions should contact Bayer Customer Service, calling toll-free 08007231010, for assistance and / or instructions on use and maintenance of the product.
Alerta De Seguridad para Contact Lens AVAIRA - Model Avaira Sphere- Registration 80130430037 - Lo...
  • Tipo de evento
    Safety alert
  • ID del evento
    1100
  • Fecha
    2011-11-18
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    To date, there are no records of product-related notifications in the National Notification System for Health Surveillance - NOTIVISA. Anvisa is following this action.
  • Causa
    The manufacturer of the product has identified the presence of silicone residue in batches of the products mentioned, which can cause from oversight or discomfort to severe eye pain or injury requiring medical treatment. symptoms, however, may vary from individual to individual.
  • Acción
    For professional ophthalmologists and distributors, the company determines that affected lots are identified and segregated. To the patients, the search of their doctor for judicious evaluation.
Alerta De Seguridad para MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B...
  • Tipo de evento
    Safety alert
  • ID del evento
    1101
  • Fecha
    2011-11-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Boston Scientific became aware, through customer complaints, that the 0.035 "internal diameter dilator (ID) may have been mislabeled as a 0.038" dilator. According to the company, injuries are not expected to occur as a result of this incorrect labeling, as it would not be possible to advance the dilator through the guidewire. Due to the exchange of labeling, there may be a delay in the procedure during the exchange of devices by the surgeon. #### UPDATE - 02/24/2012 - The company forwards the final report of the field action, declaring the total collection of the affected and forwarded products to the manufacturer. ####
  • Causa
    Incorrect labeling of product dilator - 0.0035 "internal diameter dilator labeled 0.0038".
  • Acción
    The product registration holder has already started collecting the product. Health facilities should remove all affected products from their stocks, segregate them in a safe place and identify them properly so that they are not inadvertently used. The affected products will be collected by Boston Scientific do Brasil Ltda or its distributors.
Alerta De Seguridad para Fluoroscopic X-ray System Diagnostic 94. Anvisa Registry n ° 10216710016.
  • Tipo de evento
    Safety alert
  • ID del evento
    1102
  • Fecha
    2011-12-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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, the instructions for using the equipment already inform the correct way of positioning the patients. Operators of the equipment should be aware of this by observing the position of the apparatus with respect to the legs of the patients.
  • Causa
    Possibility of fracture in the lower limbs of patients, due to incorrect positioning of the same.
  • Acción
    Philips Healthcare Brazil has already begun communicating with customers through letters to users.
Alerta De Seguridad para 16 VITER CALIBRATOR KIT. Registration Anvisa n ° 80145900790. Lot n ° 16...
  • Tipo de evento
    Safety alert
  • ID del evento
    1103
  • Fecha
    2011-12-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    -
  • Causa
    Results from patients generated using the vitros rf reagent calibrated with the 16 vitros calibrator kit, lot # 1630, may show a positive (bias) trend in the measurement range of 8.6-120 iu / ml in case of a new calibration.
  • Acción
    To users: (a) discontinue use and discard all products Calibrator Kit 16 VITROS, Lot 1630; (b) complete and return the attached Confirmation of Receipt form as soon as you receive this alert; (c) send this notice to all departments and areas using the 16 VITROS Calibrator Kit, Lot 1630. Place this notification in the vicinity of all VITROS Systems or VITROS Integrated Systems in your facility using the 16 VITROS Calibrator Kit, Lot 1630 , or together with the VITROS user documentation.
Alerta De Seguridad para BLOWTEX TURBO CONDOM. Batch affected: 16JUN11-B.
  • Tipo de evento
    Safety alert
  • ID del evento
    1105
  • Fecha
    2011-12-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Due to complaints about product disruption, the company assessed the need to collect the batch due to the risk of condom disruption during use, resulting in unwanted pregnancy or contagion of sexually transmitted diseases. Use the following telephone numbers and e-mail addresses to contact the company regarding this problem: Phone: 11- 5536-4669; consumer@blowtex.com.br; Camila Alves - e-mail: camila.alves@ansell.com; Tiago Andrade - e-mail: tiago.andrade@ansell.com; Cristiano Cisneros - email: cristiano.cisneros@ansell.com. #### UPDATE - 10/26/2012 - The Certifying Body - Instituto Falcão Bauer da Qualidade - directs Official 2682/2012, where it reports the regularization of the company with approval in the tests after the implementation of corrective actions, as demonstrated by the ELA report /L-226.676/1/2/12.####
  • Causa
    A possible manufacturing problem has been identified in lot 16jun11-b of the blowtex turbo condom, which may affect the strength of the product making it unsuitable for use. view updated in clarifications!.
  • Acción
    According to the product registration holder, corrective measures were taken by the factory to ensure the homogenization of the lubricant solution used in the product. This will prevent the problem from occurring again. As for the existing units in commerce, the company has already initiated a collection action and has already issued an alert to the population, through messages published in widely circulated media. Users are advised to check the batch number printed on the condom package before using the product - if the batch is at risk (16JUN11-B), the product should not be used but replaced with another. Distributors are advised to segregate affected products from their inventories by identifying them as unfit for use and to contact the Blowtex registration holder as soon as possible.
Alerta De Seguridad para CARDIOVERSOR DEFIBRILLADOR IMPLANTÁVEL TELIGEN 100, Model E102 (Anvisa r...
  • Tipo de evento
    Safety alert
  • ID del evento
    1106
  • Fecha
    2011-12-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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 details in attached file.
  • Causa
    Update of information regarding electrode shock impedance test.
  • Acción
    Boston Scientific do Brasil Ltda has initiated field action to inform customers that, from now on, they should contact the Company's Technical Service to obtain the measured electrode impedance value (up to 200 ohms), in the event of an alert for electrode.
Alerta De Seguridad para MAMMARY IMPLANT FILLED WITH HIGH COESIVITY GEL (Reg. Anvisa: 80152300001).
  • Tipo de evento
    Safety alert
  • ID del evento
    1107
  • Fecha
    2011-12-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    In Brazil, the Poly Implant Prothese (PIP) breast implant, imported by EMI Importação e Distribuição LTDA, has been suspended since April 1, 2010, according to Resolution RE 1558/2010. ANVISA published, on 04/01/2010, the Sanitary Alert No. 1015, available at: http://www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=1015. This information may be updated based on other evidence.
  • Causa
    Suspected serious adverse events occurring in women with poly implant prothese (pip) breast implants manufactured by poly implants protheses - france. complementation of alert 1015.
  • Acción
    ANVISA is monitoring and monitoring the news published in the foreign press regarding the Poly Implant Prothese breast implant (PIP), as well as maintaining contact with the French Agency for Sanitary Safety of Health Products (AFSSAPS) and recommends: (1) Patients should seek their doctors to perform the necessary tests and make a clinical evaluation; (2) Health professionals should contact their patients to determine the best course of action to be taken; (3) Health services and professionals should report all cases involving adverse events and / or removal of the filled-in gel filled high-strength gel (trade name of the product in Brazil) - registered with Anvisa under No. 80152300001. The notification must be made by NOTVISA, which can be accessed through the Anvisa Portal (www.anvisa.gov.br).
Alerta De Seguridad para (i). Breast Implant PIP: Mammary Implant filled with high rotation gel c...
  • Tipo de evento
    Safety alert
  • ID del evento
    1108
  • Fecha
    2012-01-27
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Within the research process of the problems presented by the breast implants described above, ANVISA, in partnership with other entities of the SNVS, carried out tax collection of several batches of breast implants for analysis in a specialized laboratory. These analyzes need to be performed in intact samples, so that the items in standards are observed. Products removed in the surgical process are considered health care waste and do not need to be submitted to laboratory analysis in this investigation. RDC No. 306, of December 07, 2004, which provides for the Technical Regulation for the management of health services waste, defines that health services are responsible for the correct management of all wastes generated by it, legal requirements, which will apply to the prostheses explanted. According to RDC No. 306/2004, breast implants fall into the Group A4 - Wastes with the possible presence of biological agents that, due to their characteristics, may present a risk of infection, such as containers and materials resulting from the health care process , which do not contain blood or body fluids in the free form. These residues may be disposed, without previous treatment, in a place duly licensed for final disposal of Health Services Waste and must be disposed of according to item 1.2 of RDC No. 306/2004, that is, in a milky white bag, to be replaced when (i). 2% of its capacity or (ii). at least once every 24 hours. For its identification, it complies with the requirements set forth in item 1.3.3 of the Resolution (as set forth in item 8 of the resolution). The surgically removed breast implants can be delivered to the patient at the request of the patient. However, the health service must proceed with the sterilization of the device and the sterilization package must be broken before delivering to the user. The interested party must sign a receipt and responsibility (guidelines according to Technical Opinion No. 06/2009 / CINFS / GGTES / ANVISA, dated March 27, 2009).
  • Causa
    Disposal of explantable mammary prostheses implant mammary is a medical device and as such, subject to sanitary regulation. according to specific regulations (rdc anvisa 185/2001) it is classified as high risk (risk class iii). according to the abnt standard nbr 14760: 2001, this device is defined as "planned implant to add or replace breast volume". thus, it can be in reparative surgeries, breast asymmetry, hypomastia, congenital changes of the chest wall, as well as aesthetic situations, such as breast enlargement.
  • Acción
    The National Health Surveillance Agency - ANVISA advises on the final destination of breast implants surgically removed.
Alerta De Seguridad para UPDATE - LOADING FOR STACKER WITH REINFORCEMENT - DUET TRS - Registratio...
  • Tipo de evento
    Safety alert
  • ID del evento
    1109
  • Fecha
    2012-01-30
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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
    Covidien claims to have received three (3) reports of fatalities and thirteen (13) serious adverse events as a consequence of the application of the Reinformer Stapler Charge - DUET TRS to the thoracic cavity. They concluded that Duet has the potential to injure adjacent anatomical structures within the thorax and may result in potentially fatal postoperative complications. Loaders for Reinforcing Stapler - DUET TRS should not use the device for thoracic surgeries, both in adult and pediatric patients. Covidien will review the DUET TRS Instructions for Use against contraindications for thoracic procedures in adult and pediatric patients. In order to guarantee patient safety, it has begun the collection to suit the Usage Instructions. This payment applies to the Reinforcing Stapler Charge - DUET TRS and only for use of this product in the thoracic cavity. Other families of Staplers and Endo GIA loads were unaffected. No cases have been reported in Brazil. ANVISA follows this action. #### UPDATE: 03/29/2012 - The company presents the conclusions of the corrective measures implemented as Amended Instructions for Use and published in DOU, as well as the collection of 24 of the 88 pieces sold. Also presents a Letter to the Client in Annex with relevant clarifications. #### UPDATE: 08/24/2012 - GENERAL COLLECTION OF THE PRODUCT. SEE CLIENT LETTER UPDATED IN ANNEX. ####
  • Causa
    Potential to injure adjacent anatomical structures within the thorax and abdomen and which may result in potentially fatal postoperative complications.
  • Acción
    Users must immediately suspend product use, inventory inventory, identify and segregate affected products. The holder of the registration in Brazil will arrange the collection.
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