Events

Alerta De Seguridad para Side Fire Needles, part of Confidence Spinal Cement System™

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

¿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
    2012-05-16
  • Fecha de publicación del evento
    2012-05-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120516.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 safety alert: depuy side fire needles, part of confidence spinal cement system™ medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning side fire needles, part of confidence spinal cement system™. during post market surveillance review of the confidence system, the manufacturer has found that the complaint rate for breakage of the side fire needles was higher than the anticipated occurrence rate in the design failure mode and effect analysis. upon evaluation of risk it was determined to reduce the level of risk, a communication would be sent out to all users of the products to reinforce proper technique and instructions for use. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 may 2012.

Device

Side Fire Needles, part of Confidence Spinal Cement System™
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Side Fire Needles, part of Confidence Spinal Cement System™
  • Manufacturer
    DePuy

Manufacturer

DePuy