Events

Alerta De Seguridad para MAMMARY IMPLANT FILLED WITH HIGH COESIVITY GEL (Reg. Anvisa: 80152300001).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Poly Implants Prothese; EMI Importação e Distribuição 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
    1107
  • Fecha
    2011-12-23
  • 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
    In Brazil, the Poly Implant Prothese (PIP) breast implant, imported by EMI Importação e Distribuição LTDA, has been suspended since April 1, 2010, according to Resolution RE 1558/2010. ANVISA published, on 04/01/2010, the Sanitary Alert No. 1015, available at: http://www.anvisa.gov.br/sistec/alerta/RelatorioAlerta.asp?ComeName=CO_SEQ_ALERTA&Parametro;=1015. This information may be updated based on other evidence.
  • Causa
    Suspected serious adverse events occurring in women with poly implant prothese (pip) breast implants manufactured by poly implants protheses - france. complementation of alert 1015.
  • Acción
    ANVISA is monitoring and monitoring the news published in the foreign press regarding the Poly Implant Prothese breast implant (PIP), as well as maintaining contact with the French Agency for Sanitary Safety of Health Products (AFSSAPS) and recommends: (1) Patients should seek their doctors to perform the necessary tests and make a clinical evaluation; (2) Health professionals should contact their patients to determine the best course of action to be taken; (3) Health services and professionals should report all cases involving adverse events and / or removal of the filled-in gel filled high-strength gel (trade name of the product in Brazil) - registered with Anvisa under No. 80152300001. The notification must be made by NOTVISA, which can be accessed through the Anvisa Portal (www.anvisa.gov.br).

Device

MAMMARY IMPLANT FILLED WITH HIGH COESIVITY GEL (Reg. Anvisa: 80152300001).

Manufacturer

Poly Implants Prothese; EMI Importação e Distribuição Ltda.
  • Source
    ANVSANVISA