Events

Safety Alert Or Field Safety Notices for Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by manufacturer #17429.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2015/034
  • Date
    2015-09-25
  • Event Date Posted
    2015-09-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/implantable-medical-devices-manufactured-by-silimed-temporary-suspension-of-the-ce-certificate
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    The German medical device regulatory authority informed MHRA on Friday 18 September 2015 that a German notified body had temporarily suspended the marketing and distribution of all medical devices manufactured by Silimed lndustria de lmplantes Ltda.A recent inspection of the manufacturing facility by the notified body identified particles on the surface of some devices.MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
  • Reason
    Suspension due to particles found on some devices (mda/2015/034).
  • Action
    Do not implant/use affected devices Quarantine devices Await further advice from the distributor(s) and/or MHRA If patients enquire they can be reassured that this situation is being investigated as a matter of priority with our European counterparts to decide on further action. However, if they would like to be kept up-to-date they can register for email updates and they will be kept informed.

Device

Implantable medical devices manufactured by Silimed lndustria de lmplantes Ltda
  • Model / Serial
  • Product Description
    The following devices distributed in the UK by Eurosurgical are affected:silicone implants for plastic surgery: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery silicone invasive devices: sizers for silicone implants silicone implants for general surgery: blocks and sheetsThe following devices distributed in the UK by Genesis Medical are affected:implants for urology: testicular implants, penile implants, vaginal stents and periuretheral constrictors
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429