MalfunctionGDG
DURAHOOK 1/4 HOOK
Received Jul 30, 2015 · Event occurred Jul 17, 2015
Report 3003898360-2015-00544 · MDR key 4952369
Device
Product problems
- Degraded
Patient
Not reported
- Not Applicable
Narrative
Description of Event or Problem
ALLEGED EVENT: THE DURAHOOKS ARE DRY ROTTING WHICH IS EVIDENT THROUGH THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73M1400048 DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.