InjuryEBC
VENUS DIAMON FLOW SYR
Received Sep 10, 2013
Report 9610902-2013-00096 · MDR key 3353161
Device
Generic name
Ebc Sealant, Pit And Fissure, And Condi
Manufacturer
Heraeus Kulzer GmbhProduct problems
- Use of Device Problem
Patient
Not reported
- Sensitivity of Teeth
Narrative
Description of Event or Problem
PLEASE REFER TO IMPORTER REPORT # (B)(4).
Additional Manufacturer Narrative
AS ALLOWED BY EXEMPTION# (B)(4), (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER (B)(4) (THE MFR). 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.
Remedial action
- Replace