Events

Alerta De Seguridad para silicone-filled breast implants

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

¿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
    2010-03-31
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20100401.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
    Press release
  • Causa
    Recall of silicone-filled breast implants the department of health (dh), through its routine surveillance today (march 31), found that a french regulatory authority has announced a recall of the silicone-filled breast implants manufactured by poly implant prothese (pip). the affected models include imghc-tx, imghc-mx and imghc-ls. there is an increase of reported adverse events concerning the problematic products in the past three years. they are mainly breakings and local complications. despite the fact that the products are not listed with dh, the department considered that there may be quality defects and safety concerns of the products after risk assessment. dh decided to inform stakeholders including hospital authority, hospitals and medical professional association about the recall. information on the recall has been posted on the dh's website. members of the public who have implanted with the affected products, or in case of doubt, should consult their doctors. the dh has not received any report of adverse events arising from the affected products. the department will closely monitor the developments of the recall. ends/wednesday, march 31, 2010.

Device

silicone-filled breast implants
  • Modelo / Serial
  • Descripción del producto
    Press release: Recall of silicone-filled breast implants
  • Manufacturer
    Poly Implant Prothese

Manufacturer

Poly Implant Prothese