MalfunctionGDG
WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HSK/PKG
Received Sep 14, 2012
Report 3003898360-2012-00405 · MDR key 2750420
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: COMPLAINT ALLEGES: THE SURGEON FINDS THAT THE ELASTICS KEEP BREAKING.
Additional Manufacturer Narrative
PER DEVICE HISTORY REPORT (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. ASSESSMENT WAS CONDUCTED AND NO CHARGES 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 MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.