Events

Alerta De Seguridad para Catheter Valve

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Coloplast.

¿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
  • Fecha
    2011-11-17
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111117c.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device recall: coloplast catheter valve medical device manufacturer, coloplast, is initiating a medical device recall regarding three lots (2769329, 2799062 and 2823831) of catheter valve (item number: 380851). a sterility test on coloplast catheter valve has failed, which raises concerns over the sterility of the catheter valves. coloplast has not received any complaint on the catheter valve related to this issue and therefore no signals for safety concerns. it is assumed that the catheter valve is used in a non-sterile environment. under this assumption the lack of sterility is very unlike to affect the patient and user’s safety. coloplast is notifying the affected customers. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.

Device

Catheter Valve
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Coloplast Catheter Valve
  • Manufacturer
    Coloplast

Manufacturer

Coloplast