Events

Alerta De Seguridad para neurovascular STRYKER TRASFORM occlusion balloon catheters

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 Stryker Neurovascular || Stryker Neurovascular Cork.

¿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
    R1608-349
  • Número del evento
    2014DM-0011080
  • Fecha
    2016-08-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • 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 reports that it has detected the possibility that the referenced devices were manufactured using a microscopically machined tube that had not been rinsed after the application of a cleaning solution as part of the manufacturing process, leading to its use causing possible adverse events on the patients.

Device

neurovascular STRYKER TRASFORM occlusion balloon catheters
  • Modelo / Serial
    M003ESC04100, lot 18958702.
  • Descripción del producto
    The neurovascular STRYKER TRASFORM occlusion balloon catheters have been designed for use in neurological and peripheral vasculature for temporary arrest or control of blood flow, treatment of vasospasms and balloon-assisted embolization of intracranial aneurysms.
  • Manufacturer
    Stryker Neurovascular || Stryker Neurovascular Cork

Manufacturer

Stryker Neurovascular || Stryker Neurovascular Cork
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA