Events

Safety Alert for Cushion CYSM-289

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Not specified.

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
    8
  • Date
    2018-11-30
  • 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
    The medical device and its packaging do not bear the ce conformity marking and the identification number of the notified body, which does not comply with the requirements of articles 38, 39 and 40 of the regulation; there is no label on the medical device, which is not in accordance with annex 14.1 of the regulation. requirements; the name of the manufacturer, its address and the manufacturer's authorized representative in the european economic area are not specified, which does not comply with the requirements of annex 1, paragraph 14.3.1. the batch / serial number is not specified, which does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation.
  • Action
    Do not allow to enter the Lithuanian market

Device

Cushion CYSM-289

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH