Events

Alerta De Seguridad para Filter System for Vena Cava BARD

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 Cr Bard Inc || Bard Peripheral Vascular, Inc..

¿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
    R1602-79
  • Número del evento
    2014DM-0011295
  • Fecha
    2016-02-25
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 that the stopcock may present cracks, leading to potential adverse events on patients or patients at the time of the procedure.

Device

Filter System for Vena Cava BARD
  • Modelo / Serial
    DL900F, lots GFZJ0277 and GFZJ0425.
  • Descripción del producto
    The DENALI filter is indicated for the prevention of recurrent pulmonary emboli after being implanted permanently in the vena cava, in the following situations: • pulmonary thromboembolism when anticoagulants are contraindicated. • Failure of anticoagulant treatment for thromboembolism. • Emergency treatment after pulmonary embolism in which no major benefits are expected with conventional treatment. • Chronic and recurrent pulmonary embolism in which the anticoagulant treatment has failed or is contraindicated.
  • Manufacturer
    Cr Bard Inc || Bard Peripheral Vascular, Inc.

Manufacturer

Cr Bard Inc || Bard Peripheral Vascular, Inc.