DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG
Received Apr 3, 2015 · Event occurred Mar 10, 2015
Report 3003898360-2015-00227 · MDR key 4661823
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT ALLEGES THAT THE ELASTICS ON THE PRODUCT ARE BRITTLE AND BREAKING. FOUND PRIOR TO USE ON PATIENT, DURING INSPECTION/ FUNCTIONALITY TESTING. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
(B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME, DUE TO THE LACK OF DEFECTIVE PRODUCT, IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT AND TO DETERMINE THE ROOT CAUSE. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.