Events

Alerta De Seguridad para Carotid Stent System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Cordis Europa N.V || Cordis Corporation.

¿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
    R1605-212
  • Número del evento
    2012DM-0000902-R1
  • Fecha
    2016-05-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has determined that the products manufactured between april 27, 2015 and november 22, 2015, have been associated with an increase in the frequency of incidents of difficulty of deployment and in some cases of separation of the axis of the external member which results in the inability to deploy or its partial deployment, leading to the occurrence of adverse events on patients.

Device

Carotid Stent System
  • Modelo / Serial
    PRECISE PRO RX / PCxxyyXCE, specific lots.
  • Descripción del producto
    Carotid stents are indicated for use in patients with stenotic lesions of the carotid artery (s).
  • Manufacturer
    Cordis Europa N.V || Cordis Corporation

Manufacturer

Cordis Europa N.V || Cordis Corporation