Events

Safety Alert for Wrist Brace AB 14

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by By ABC Tip Saglik Spor Malzemeleri Teks. There. Ins. San. Ve Tic. Ltd. Sti., Turkey Sender FB Saglik Rekstil Dis Ticaret Ltd., Turkey.

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
    10
  • Date
    2016-03-23
  • 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 ce marking is not affixed to the medical device (does not meet the requirements of mn 4: 2009 38). batch / serial number not specified anywhere (does not meet the requirements of mn 4: 2009, annex 1, paragraph 14.3.4), no medical device identifier information is available on the medical device itself (not in accordance with mn 4: 2009 annex 1, clause 14.3.2), not specified by manufacturer (does not conform to mn 4) : 2009 annex 1, clause 14.3.1).
  • Action
    Disallowed to market

Device

Wrist Brace AB 14

Manufacturer

By ABC Tip Saglik Spor Malzemeleri Teks. There. Ins. San. Ve Tic. Ltd. Sti., Turkey Sender FB Sag...