Events

Alerta De Seguridad para Stent Graft Dominus Stent, Straight and Straight models with Free Flow Anvisa Record: 10159030093). Stent Graft Linus Endoprosthesis, Free-Flow Iliac Aorto Model with Patch (Anvisa Record: 10159030096).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Braile Biomédica Indústria Comércio e Representações 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
    1365
  • Fecha
    2014-02-27
  • 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
    According to the company's statement, if the Instructions for Use of the products are not followed correctly, improper use may lead to the impossibility of performing the surgical procedure (minimally invasive) and even cause the situation to evolve to death - with possible including during catheter rupture. Check Alert Messages posted by the company: WAITING FOR LINK UPDATE
  • Causa
    Company safety notice regarding the correct use of the products.
  • Acción
    The company is sending alert messages to its customers. In order to prevent further occurrences of adverse events / technical complaints with these products, the company is implementing corrective actions for technical improvement of the products.

Device

Stent Graft Dominus Stent, Straight and Straight models with Free Flow Anvisa Record: 10159030093...

Manufacturer

Braile Biomédica Indústria Comércio e Representações Ltda.