Events

Alerta De Seguridad para Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing

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

¿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
    2013-01-10
  • Fecha de publicación del evento
    2013-01-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130110.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: mentor breast implants, winged infusion sets, and psi‐tec tubing the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning mentor breast implant, winged infusion sets, and psi‐tec tubing , manufactured by mentor medical systems b.V. the manufacturer has identified an issue where some lots of these products were inadvertently shipped out beyond their expiration date because of a scanning error in the company’s inventory and distribution system. some of the lots may contain a secondary inventory label with an incorrect expiry date (different from the product label). to date, no complaints have been reported that are connected to this issue. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con216883 if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 january 2013.

Device

Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing
  • Manufacturer
    Mentor Medical Systems B.V

Manufacturer

Mentor Medical Systems B.V