MalfunctionGDG
WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Dec 21, 2012 · Event occurred Nov 1, 2012
Report 3003898360-2012-00626 · MDR key 2889162
Device
Product problems
- Degraded
- Out-Of-Box Failure
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT.
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: DURING INSPECTION/FUNCTIONALITY TESTING WAS 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.