Events

Safety Alert for Dental collagen membranes - Colo Gide GTR

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Cologenesis Healthcare Pvt. Ltd., India.

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
    7
  • Date
    2018-10-19
  • 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
    Medical devices and their packaging do not bear the ce marking and the number of the notified body, which does not comply with the requirements of articles 38, 39 and 40 of the regulation. instructions for use not included in medical devices are not in compliance with the requirements of annex 1, paragraph 14.1 of the regulation. there is no data on the manufacturer's authorized representative in the european economic area for medical devices, which does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation.
  • Action
    Do not allow to enter the Lithuanian market

Device

Dental collagen membranes - Colo Gide GTR

Manufacturer

Cologenesis Healthcare Pvt. Ltd., India
  • Manufacturers representative
    Individual
  • Source
    MH