MalfunctionGDG
DURAHOOK 1/4 HOOK
Received Oct 8, 2015 · Event occurred Aug 28, 2015
Report 3003898360-2015-00731 · MDR key 5138454
Device
Generic name
Instrument,surgical,non-powered
Catalog number
382800
Lot number
73D1500050
Product problems
- Break
- Material Discolored
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEWS FOR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG, LOT NUMBER 73D1500050 INVESTIGATIONS DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
ALLEGED EVENT: THE ITEM IS DISCOLORED AND BREAKS WHEN STRETCHED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.