MalfunctionGDG
WECK DURAHOOK 1/4" HOOK 10 PKG/BX 6 HKS/PKG
Received Jul 22, 2011 · Event occurred Jun 6, 2011
Report 3003898360-2011-00319 · MDR key 2192918
Device
Product problems
- Degraded
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
UNK IF SAMPLE IS AVAILABLE FOR EVAL, THEREFORE, INVESTIGATION IS INCOMPLETE. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem
THE EVENT IS REPORTED AS: COMPLAINT ALLEGED: CHILDREN'S HOSPITAL NOTICED THE ELASTICS HAD DETERIORATED AWAY FROM THE HOOKS BEFORE HE OPENED THE PACKAGE. PRODUCT WAS NOT OPENED OR USED. HOSPITAL PAPERWORK SUBMITTED STATES THAT THERE WAS NO PT HARM OR A CLOSE CALL.
Remedial action
- Other