Events

Alerte De Sécurité sur TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - 210 cc) - Record 80145901328

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 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

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
    1377
  • Date
    2014-04-04
  • 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 company reports that to date, there are no reports of customers reporting product complaints or adverse events related to this problem. According to the risk analysis of the manufacturer, in relation to the deviation found, it is unlikely that an adverse health consequence will occur.
  • Cause
    The company holding the registration informs that the manufacturer has identified that some units of the texturized gel mammary implants product manufactured between 2002 and 2010 were identified with an incorrect expiration date and distributed to some countries between 2006 and 2010, in addition to the date of expiration. this deviation was detected after reviewing the quality data in december 2013.
  • Action
    The company asks physicians who have used the product to verify the period of coverage of this field action, as well as the product code, serial number and lot involved (Appendix I - Customer Letter). The company also recommends that the physician monitor patients according to standard protocols. If there is any medical doubt, the professional should contact the local representatives for the best assistance.

Device

TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda