Events

Alerte De Sécurité sur Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Risk Affected models: See alert on Anvisa Portal

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2206
  • Date
    2017-02-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    - Segregate the product so that it is not used - Do not deploy the affected product
  • Cause
    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 ### update: the suspension of certification was revoked on 8/1/2017 "(...)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