MalfunctionGDG
DERMAHOOK 1/2 HOOK
Received Oct 27, 2014 · Event occurred Sep 26, 2014
Report 3003898360-2014-00866 · MDR key 4224564
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY REVIEW INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.
Description of Event or Problem
ALLEGED EVENT: WHEN OPENING THE DERMAHOOKS PACKAGE DURING SURGERY, THE NURSE NOTICED THAT THE RUBBER BANDS WERE BROKEN. THE HOOKS WERE NOT USED ON THE PT. THE PT'S CONDITION IS FINE.