WECK DERMAHOOK 1/2" HOOK 10 PKG/BX 6 HKS/PKG
Received Sep 24, 2012 · Event occurred Aug 8, 2012
Report 3003898360-2012-00424 · MDR key 2759566
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 ELASTIC PORTION IS FALLING APART WITHIN THE PACKAGE. IT IS BROKEN DOWN IN MANY PIECES." "ISSUE WAS REPORTED PRIOR TO USE ON A PT DURING INSPECTION/FUNCTIONALITY TESTING (NOT DURING INCOMING INSPECTION OR ROUTINE INVENTORY CHECK)." NO PT INJURY REPORTED.
Additional Manufacturer Narrative
PER DEVICE HISTORY REPORT (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 MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.