inforMED
InjuryLLN

CASE IV

Received Jun 18, 1999 · Event occurred Apr 21, 1999

Report 2118418-1999-00001 · MDR key 228293

Device

Generic name

Computer Aided Sensory Evaluator

Model number

IV

Catalog number

5000

Lot number

*

Product problems

  • Unknown (for use when the device problem is not known)

Patient

*

  • Therapy/non-surgical treatment, additional
  • Burn, Thermal
  • Treatment with medication(s)

Narrative

Description of Event or Problem

AFTER BEING GIVEN THE CASE IV HEAT/PAIN TEST, THE PT EXPERIENCED A SECOND DEGREE BURN (RED SKIN, SMALL ULCER) ON THE SITE WHERE THE THERMAL STIMULATOR WAS ATTACHED. TREATMENT CONSISTED OF FLAMMAZINE DAILY UNDER A BANDAGE.

Remedial action

  • Inspection