Events

Safety Alert for Sterile Water Gel Modified by Hyaluronic Acid, Hyalrepair / mesolift Hyalrepair

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Laboratory in Tuscany, Russia.

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
    5
  • Date
    2017-06-02
  • 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
    Neither on the outer packaging nor on the label nor in the instructions for use, an authorized representative of the european economic area (not in compliance with subparagraph 14.3.1 of annex 1 to the regulation); neither the ce marking nor the number of the notified body appear on the outer packaging, nor on the label or in the instructions for use (does not comply with points 38, 39 and 40 of the regulation). in addition to the ce conformity marking, the number of the notified body is not indicated (does not correspond to point 40 of the regulation).
  • Action
    Not allowed to enter the Lithuanian market

Device

Sterile Water Gel Modified by Hyaluronic Acid, Hyalrepair / mesolift Hyalrepair

Manufacturer

Laboratory in Tuscany, Russia
  • Manufacturers representative
    JSC Embilika
  • Source
    MH