Events

Alerte De Sécurité sur BIOSSIMETRIC - Record 80434370001 - All Batches in all presentations.

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 MTC MEDICAL COMÉRCIO INDÚSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS.

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
    1211
  • Date
    2012-12-05
  • 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
    The product is an injectable implant, the base of polymethylmethacrylate (PMMA), used in repairing plastics and manufactured by the company MTC Medical Trade Industry Import and Export of Biomedical Products. Anvisa found that the company was not manufacturing the product as recorded. In investigative inspection, the Agency detected the nonobservance of items foreseen in RDC 59/2000, which entails a high degree of risk to the users' health. The company must collect all available lots on the market.
  • Cause
    Company does not manufacture the product according to the registration granted by anvisa. http://portal.Anvisa.Gov.Br/wps/wcm/connect/23caf2804db60436ad4fbdd6059e5711/re5139mtc.Pdf?mod=ajperes.
  • Action
    Immediate disruption of use, stock segregation, product recall on the market.

Device

BIOSSIMETRIC - Record 80434370001 - All Batches in all presentations.

Manufacturer

MTC MEDICAL COMÉRCIO INDÚSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS BIOMÉDICOS
  • Source
    ANVSANVISA