Events

Safety Alert for Inactive soft tissue implants (CRM Gel, CRM Dur, Genefill Soft Fill, Soft Touch, Hyacorp Lips, Hyacorp Face, Hyacorp HS, Hyacorp H 1000, Genefill Contour, Hyacorp MFL 1, Hyacorp MLF 2, Genefill Ultra, Ephyal , Genefill DX, CRM DX)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Bioscience GmbH, Germany.

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
  • Event Number
    1
  • Date
    2016-01-07
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Extra notes in the data
  • Reason
    Conformity marking ce and notified body no. 0297 and 1252 are used illegally.
  • Action
    Withdrawn from the market

Device

Inactive soft tissue implants (CRM Gel, CRM Dur, Genefill Soft Fill, Soft Touch, Hyacorp Lips, Hy...

Manufacturer

Bioscience GmbH, Germany
  • Manufacturers representative
    Unknown
  • Source
    MH