Events

Alerta De Seguridad para GOLDEN CARE Tracheotomy Cannula

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 Hitec Medical Co. Ltd.

¿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
    R1711-534
  • Número del evento
    2015DM-0013886
  • Fecha
    2017-11-20
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • 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 informs that he has received the report of an adverse event that generated the doubling of the referenced device, reason for which after analyzing the possible causes has decided to preventively change the mold of conformation and modify the density of the material used, this situation could lead to that potential adverse events occur on patients.

Device

GOLDEN CARE Tracheotomy Cannula
  • Modelo / Serial
    GCA-HTC0570C, all lots
  • Descripción del producto
    The tracheostomy tube is used in general anesthesia, intensive care and emergency medicine for the management of airways and mechanical ventilation. The tube is inserted into the patient's trachea through an incision in the trachea.
  • Manufacturer
    Hitec Medical Co. Ltd

Manufacturer

Hitec Medical Co. Ltd
  • Source
    NIDFSINVIMA