WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Dec 12, 2012 · Event occurred Nov 6, 2012
Report 3003898360-2012-00580 · MDR key 2900849
Device
Product problems
- Degraded
- Device Damaged Prior to Use
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE COMPLAINANT OBSERVED THAT SEVERAL OF THE ELASTIC PORTIONS OF THE DERMAHOOK ARE SIGNIFICANTLY DEGRADED PRIOR TO THE PACKAGES BEING OPENED. NO PT INJURY REPORTED.
Additional Manufacturer Narrative
PER DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. ASSESSMENT WAS CONDUCTED AND NO CHANGES REQUIRED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.