Events

Alerta De Seguridad para Zilver Quick Change Stent, ZIVX5-125-7-3.0 models; ZIVX5-125-9-3.0; ZIVX5-125-8-3.0; ZIVX5-125-8-4.0, registration 10212990244, hazard class IV, Lots: C1001040; C1010612; C1145789; C980159; C1117285; C1139850; C910457; C991015; C1002635; C1009790.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por E. Tamussino & CIA.; COOK IRELAND LTDA, O HALLORAN ROAD, NATIONAL TECHNOLOGICAL PARK.

¿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
    1804
  • Fecha
    2016-01-22
  • 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
    Recommendations to users and patients: Do not use the product if any deviations in quality are observed and notify the company as soon as possible so that the necessary measures are taken
  • Causa
    Cook ireland ltd has identified potential nonconformity for the product as during its implementation the release system has failed the drive. a device joint failure may result in partial stent implantation. as a clinical effect of partial implantation: surgical intervention may be necessary, or may result in vessel trauma.
  • Acción
    Gathering. Action code 2015FA0010. The Recall was performed because it could cause potential adverse events, the manufacturer initiated voluntary collection of the listed lots.

Device

Zilver Quick Change Stent, ZIVX5-125-7-3.0 models; ZIVX5-125-9-3.0; ZIVX5-125-8-3.0; ZIVX5-125-8-...

Manufacturer

E. Tamussino & CIA.; COOK IRELAND LTDA, O HALLORAN ROAD, NATIONAL TECHNOLOGICAL PARK
  • Source
    ANVSANVISA