Events

Alerta De Seguridad para TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - 210 cc) - Record 80145901328

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1377
  • Fecha
    2014-04-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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