Events

Alerta De Seguridad para Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Risk Affected models: See alert on Anvisa Portal

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S..

¿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
    2206
  • Fecha
    2017-02-20
  • 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
    - Segregate the product so that it is not used - Do not deploy the affected product
  • Causa
    Suspension of the use of the inmetro compliance seal for the round collection family of products due to the presence of particles detected in a sample collected during the annual maintenance process. ### update: the suspension of certification was revoked on 8/1/2017 "(...) after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, through an extraordinary audit and the tests required by the regulation ..". however, "(...) revocation of the suspension is applicable only to products produced and imported after confirmation of the effectiveness of the corrective actions implemented by the manufacturer, and the holder of the certification must keep the stock of previously produced products locked and under suspicion, (...) ".
  • Acción
    Field Action Code 001/17 triggered under the responsibility of the company EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will make inventory segregation, communication of surgeons and investigation of the event.

Device

Technical name: MAMMAL IMPLANTS ANVISA registration number: 80674930007 Risk class: III - High Ri...

Manufacturer

EUROSILICONE BRASIL IMPORTAÇÃO E EXPORTAÇÃO LTDA; EUROSILICONE S.A.S.
  • Source
    ANVSANVISA