MalfunctionEHJ
VENUS SUPRA
Received Sep 17, 2013
Report 3005665377-2013-00001 · MDR key 3368371
Device
Generic name
Ehj-abrasive Disk
Manufacturer
Heraeus Kulzer GmbhProduct problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
(B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION.
Remedial action
- Replace