Events

Safety Alert for Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Mentor Medical Systems B.V.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-01-10
  • Event Date Posted
    2013-01-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130110.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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
  • Model / Serial
  • Product Description
    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