Events

Alerta De Seguridad para InterGard Knitted Silver Vascular Prothesis - IGK 1470S

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INTERVASCULAR.

¿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
    587
  • Fecha
    2002-04-18
  • 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
    1 - ANVISA / TECNOVIGILANCIA has verified the existence of registration in Brazil and is making contact with the company to provide a solution to the problem. This solution should be extended to all users of these products in the national territory. For more information: ANVISA Technovigilance Unit, by phone 0xx61-4481485 or 448.1331- email: tecnovigilância@anvisa.gov.br 2 - InterVascular letter dated July 24, 2002, stating that the recall was completed at the end of April of 2002.
  • Causa
    Possible exchange in the packaging of an igk 1407s for an igk 1809s (igk 1809s that may have been bundled in place of an igk1407s) 03 appliances may have been affected in brazil.
  • Acción
    Letter of notification from INTERVASCULAR / FRANCE dated 14.03.02, sent to distributors requesting the return of the affected product and if it has been implanted, requests that the name of the hospital and date of implantation be informed.

Device

InterGard Knitted Silver Vascular Prothesis - IGK 1470S

Manufacturer

INTERVASCULAR
  • Source
    ANVSANVISA