MalfunctionGDG
DERMAHOOK 1/2
Received Jul 3, 2014 · Event occurred Jun 11, 2014
Report 3003898360-2014-00416 · MDR key 4014985
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ALLEGED EVENT: DURING INSPECTION/FUNCTIONALITY TESTING, IT WAS DISCOVERED THAT SEVERAL OF THE RUBBER BANDS WERE BROKEN. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
THE DEVICE HISTORY REPORT REVIEW (DHR) OF THE PRODUCT DERMAHOOK 1/2 HOOK 10 PKG/BX 6 HKS/PKG, LOT # 01A1400018 WAS MANUFACTURED ON (B)(4) 2014 A TOTAL OF (B)(4) PIECES. LOT WAS RELEASED ON (B)(4) 2014. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS ON-GOING AT TIME OF THIS REPORT.