MalfunctionGDG
DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG
Received Sep 8, 2015 · Event occurred Aug 27, 2015
Report 3003898360-2015-00640 · MDR key 5061805
Device
Product problems
- Degraded
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73E1500060 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: RUBBER BANDS ARE POPPING AND APPEAR TO BE DRY ROTTED. THERE IS NO REPORTED PATIENT INVOLVEMENT.