Events

Alerta De Seguridad para Mentor breast implants

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

¿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
    2013-05-21
  • Fecha de publicación del evento
    2013-05-21
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130521b.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 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning breast implants manufactured by mentor. the affected sales code and lot number are 3545160 and 5741158 respectively, with expiry date in may 2012. the manufacturer has identified an issue where one lot of these products was inadvertently shipped out beyond its expiration date because of a scanning error in the company’s inventory and distribution system. the affected lot 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. the manufacturer advises users to immediately identify and quarantine all unused product and return them to their supplier for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con273701 if you are in possession of the product, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

Mentor breast implants
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Mentor breast implants
  • Manufacturer
    Mentor

Manufacturer

Mentor