inforMED
MalfunctionLGG

ION NITRIDED CAST CUTTER BLADE

Received Dec 8, 2010 · Event occurred Nov 10, 2010

Report 9616696-2010-00363 · MDR key 1931447

Device

Generic name

Cast Removal Instrument

Catalog number

0840023000

Lot number

UNK

Product problems

  • Overheating of Device

Patient

UNK

  • Abrasion
  • Erythema

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE BLADE BEGAN TO OVERHEAT DURING A SERIAL CAST REMOVAL, BEING USED WITH A CAST CUTTER HANDPIECE. THE CAST EXTENDED FROM KNEE TO ANKLE. UPON REMOVAL OF THE CAST, SLIGHT REDNESS AND A MILD ABRASION WAS FOUND ON THE PT'S LEG WHERE THE BLADE WAS BEING USED TO REMOVE THE CAST. NO ADDITIONAL TREATMENT WAS GIVEN TO THE PT DUE TO THE EVENT. NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE EVENT.

Additional Manufacturer Narrative

THE BLADE WAS DISCARDED BY THE ACCOUNT AND IS NOT AVAILABLE FOR INVESTIGATION.