Events

Alerta De Seguridad para Trauma Pins and Drills

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

¿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
    2012-04-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120423c.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
    Field safety notice: smith & nephew, inc. trauma pins and drills medical device manufacturer, smith & nephew, inc., has issued a field safety notice concerning the product recall of certain batches of trauma pins and drills. smith & nephew found that burrs in packaging hinged trays may cause pin holes or fiber tears at or near where the hinges are situated in the tyvek pouch, potentially causing a sterile barrier breach of the products. the affected batches are listed in the attachment. although there have been no reports, any device with a violated sterile barrier may present increased risk of intraoperative infection. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Trauma Pins and Drills
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smith & Nephew, Inc. Trauma Pins and Drills
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew