MalfunctionGDG
WECK DERMA HOOK
Received Apr 19, 2011 · Event occurred Jan 24, 2011
Report 3003898360-2011-00232 · MDR key 2093392
Device
Generic name
Derma Hook
Manufacturer
Teleflex MedicalModel number
NACatalog number
382805
Lot number
01H1000446
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO SAMPLE WILL BE RETURNED FOR INVESTIGATION. INVESTIGATION IS INCOMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem
THE EVENT IS REPORTED AS: DURING A BRAIN SURGERY, ONE OF THE DEVICES BROKE LOOSE ALMOST CAUSING THE SCALP FLAP TO CLOSE OVER THE BRAIN TISSUE. NO PT INJURY REPORTED.
Remedial action
- Other