MalfunctionGDG
WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Dec 21, 2012 · Event occurred Nov 1, 2012
Report 3003898360-2012-00627 · MDR key 2889163
Device
Product problems
- Degraded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: DURING INSPECTION/FUNCTIONALITY TESTING WHEN OPENING A PACKAGE THE HOSPITAL FOUND THAT THE ELASTIC PORTION OF THE DERMAHOOK WAS SIGNIFICANTLY DEGRADED. ISSUE WAS REPORTED PRIOR TO USE ON A PT. NO PT INJURY REPORTED.
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.