Events

Safety Alert for Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Risk Affected models: See alert on Anvisa Portal

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S..

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
    2206
  • Date
    2017-02-20
  • 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
    - Segregate the product so that it is not used - Do not deploy the affected product
  • Reason
    Suspension of the use of the inmetro compliance seal for the round collection family of products due to the presence of particles detected in a sample collected during the annual maintenance process. ### update: the suspension of certification was revoked on 8/1/2017 "(...) after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, through an extraordinary audit and the tests required by the regulation ..". however, "(...) revocation of the suspension is applicable only to products produced and imported after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, and the holder of the certification must keep the stock of previously produced products locked and under suspicion, (...) ".
  • Action
    Field Action Code 001/17 triggered under the responsibility of the company EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will make inventory segregation, communication of surgeons and investigation of the event.

Device

Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Ri...

Manufacturer

EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S.
  • Source
    ANVSANVISA