Events

Alerte De Sécurité sur Trade name: Comp. Femoral Cementate Technical Name: Implantable Material ANVISA Registration Number: 10417940046 Hazard Class: III Model Affected: Femoral Modular III Component Right Affected Series Numbers: 00219S and 00202S

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 MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes S.A..

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
    2272
  • Date
    2017-04-19
  • 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
    Non-deployed products should be segregated and returned to the MDT company. We recommend to users and patients that there are some technical complaints and adverse events involving the products mentioned in the Field Action (which can be verified on the Traceability Labels sent to each product), the Distributor and the MDT Manufacturer and / or through the NOTIVISA System. To the users, it is confirmed that clinical follow-up of patients already implanted is not necessary, since possible failures are perceptible during the implantation procedure, making it possible to substitute the product and / or make the surgery unfeasible.
  • Cause
    When the product was opened it was identified that it was a modular female component iii medium and not a modular female modular component iii as described in the internal and external labels.
  • Action
    Field Action Code AC 02.2017 triggered under the responsibility of the company MDT Industria Comércio Importacao e Exportação de Implantes SA Company will make collection for later return to the manufacturer.

Device

Trade name: Comp. Femoral Cementate Technical Name: Implantable Material ANVISA Registration Numb...

Manufacturer

MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importaç...