MalfunctionGDG
WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Aug 20, 2012 · Event occurred Aug 2, 2012
Report 3003898360-2012-00331 · MDR key 2712656
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: ALLEGED ISSUE: RUBBER BANDS ARE BROKEN INTO PIECES INSIDE THE PACKAGE. ISSUE WAS REPORTED BEFORE USE ON PATIENT. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
PER DEVICE HISTORY REPORT (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT.