Events

Safety Alert for Donor chairs

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Mobile Designs Inc., USA.

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
    2
  • Date
    2017-04-20
  • 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 do not bear the ce conformity marking (not in compliance with the requirement of article 38 of the regulation); there is no information on the manufacturer's authorized representative in the european economic area on the label and in the instructions for use of the medical device (does not meet the requirements of annex 1, paragraphs 14.3.1 and 14.6.1 of the regulation); batch / serial number not indicated on the label of the medical device (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); conditions for the storage and / or maintenance of a medical device not mentioned in the label and instructions for use of the medical device (for example, it does not specify the means to be cleaned and disinfected by these chairs) (does not comply with point 14.3.9 of annex 1 to the regulation); after checking the eu database of medical devices eudamed and the lithuanian medical devices information system mepris, no information was found about the mobile folding blood donor seats md 2500 and their manufacturer mobile designs inc., usa.
  • Action
    Not allowed to enter the Lithuanian market

Device

Donor chairs

Manufacturer

Mobile Designs Inc., USA
  • Manufacturers representative
    UAB ABT Baltic
  • Source
    MH