Events

Alerta De Seguridad para 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
    2013-01-22
  • Fecha de publicación del evento
    2013-01-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130122b.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 confidence spinal cement system medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning all lots of confidence spinal cement system 5cc kit, confidence spinal cement system 7cc kit, confidence spinal cement system 11cc plus kit and confidence spinal cement system kit(catalogue numbers 283905000, 283907000, 283910000 and 283913000). the cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to additional anesthesia in another surgical procedure. according to the local supplier, the affected products were distributed in hong kong and have been located and returned. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

Confidence Spinal Cement System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Confidence Spinal Cement System
  • Manufacturer
    DePuy

Manufacturer

DePuy