inforMED
MalfunctionGDG

WECK DURAHOOK NEURO ELASTIC RETRACTORS, 1/4"

Received May 17, 2011 · Event occurred Apr 27, 2011

Report 3003898360-2011-00243 · MDR key 2113815

Device

Generic name

Durahook Neuro Elastic Retractor

Manufacturer

Teleflex Medical

Catalog number

382800

Lot number

01J1000548

Product problems

  • Component(s), broken

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

Description of Event or Problem

THE EVENT IS REPORTED AS: COMPLAINT ALLEGED THAT THE RUBBER BANDS WERE DEFECTIVE. THEY WERE BREAKING WHILE THE OPERATING ROOM STAFF WAS PREPARING TO USE THEM. THERE WAS NO PT INVOLVEMENT.

Remedial action

  • Other