Events

Safety Alert for Vascular Graft Prosthesis: (1) Distaflo Bypass, (2) Flexible with Small Bubble. Catalog No. (1) DF5006SC, DF5007SC, DF6006SC, DF6007SC, DF7006SC, DF8006SC; (2) F1006TWS, F3006TWSC, F310086TWS, F310086TWSC, F5006S, F5006SC, F5006TWS, F5006TWSC, F5008S, F5008TWS, F5008TWSC, F6006TWS, F6006TWSC, F7004TWS, F7005TWS, F7005TWSC, F7006S, F7006SC, F7006TWS, F7006TWSC, F7007TWS, F7007TWSC, F7008S, F7008SC , F7008TWS, F7008TWS, F7008TWS, F70N75TSC, F70N75TWS, F70T74TSC, F70T74TWS, F70T85TWS, F70T85TWS, F8006S, F8006SC, F8006TWS, F8007TWS, F8007TWS, F8007TWSC, F8008S, F8008SC, F8008TWS, F8008TWSC

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by IMPRA Inc Div C R Bard Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    242
  • Date
    2000-12-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The uk has demanded of impra to provide better instructions for use of the aforementioned prostheses to alert doctors in removing the small bubble and also demanded of impra withdrawing the product from the market to remedy the problem. the manufacturer initiated the recall of the defective product outside the united states by mail dated may 1999 and august 2000.
  • Action
    Make sure that you have received the dated May 1999 and August 2000 correspondence from Impra. Identify and isolate any affected product from your inventory. ECRI recommends that you inform if any of the above units have been deployed in your institution and by whom. Tell the implant surgeon that the product is subject to removal. It is up to the cardiac surgeon to decide on the need for medical intervention in patients who have been implanted with the product. No action is necessary in the United States. For removal instructions, contact your local representative or directly with Impra at (1) (480) 894-9515 in the United States. ANVISA recommends that your establishment ensure that all patients who have these products in place are followed periodically and that this follow-up is documented in order to protect their implantable physicians and their establishment from a legal point of view. If it is necessary to replace the implants, if there is any difficulty in recovering from the manufacturer, immediately contact the ANVISA Technovigilance for arrangements.

Device

Vascular Graft Prosthesis: (1) Distaflo Bypass, (2) Flexible with Small Bubble. Catalog No. (1) D...

Manufacturer

IMPRA Inc Div C R Bard Inc
  • Source
    ANVSANVISA