inforMED
InjuryLLN

CASE IV

Received Apr 29, 1997 · Event occurred Mar 31, 1997

Report 2118418-1997-00001 · MDR key 87225

Device

Generic name

Computer Aided Sensory Evaluator

Model number

IV

Catalog number

5000

Lot number

*

Patient

42 YR

Narrative

Description of Event or Problem

WHILE USING THE DEVICES HEAT PAIN ANALOG VISUAL SCALE (HPAVS) TEST A PATIENT WAS GIVEN THE MAXIMUM STIMULATION JND 25 WHICH CAUSED A 3RD DEGREE BURN THE SIZE OF A DIME ON THE DORSUM OF HIS LEFT FOOT. THE PATIENT HAD BEEN PREVIOUSLY TESTED INSENSITIVE USING OTHER. SAME DEVICE TEST.

Remedial action

  • Inspection