InjuryEBC
VENUS DIAMOND FLOW
Received Dec 5, 2013
Report 9610902-2013-00117 · MDR key 3520729
Device
Generic name
Ebc Sealant, Pit And Fissure, And Condi
Manufacturer
Heraeus Kulzer GmbhProduct problems
- Loss of or Failure to Bond
- Shelf Life Exceeded
Patient
Not reported
- Difficulty Chewing
Narrative
Description of Event or Problem
PLEASE REFER IMPORTER REPORT # 1925223-2013-00168.
Additional Manufacturer Narrative
(B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLAINT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE DENTIST USED THE MATERIAL AFTER IT EXPIRED WHICH COULD HAVE LED TO BOND FAILURE. CAPA WERE NOT RECOMMENDED AS EFFICACY OF MATERIAL CANNOT BE GUARANTEED AFTER EXPIRATION AND USE IS WARNED AGAINST IN THE DIRECTIONS FOR USE.