InjuryEGJ
ACTION PATCH
Received Feb 21, 2008 · Event occurred Feb 8, 2008
Report MW5005650 · MDR key 1002845
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
20 YR
- Blister(s)
- Erythema
- Discomfort
- Therapy/non-surgical treatment, additional
- Burn, Thermal
Narrative
Description of Event or Problem
PATIENT STATED, THAT SHE EXPERIENCED A STINGING SENSATION UNDER THE DISPERSIVE ELECTRODE OF THE ACTION PATCH THAT WAS PLACED ON HER IN 2008. SHE KEPT THE PATCH ON FOR APPROX 1 1/2 HOURS UNTIL LIGHT TURNED OFF, AS SHE WAS INSTRUCTED TO DO. SHE THEN REMOVED THE PATCH AND NOTED SEVERAL SMALL BLISTERS. SHE PRESENTED TO THE HAND THERAPY CLINIC THREE DAYS LATER WITH LOCALIZED REDNESS AND 3-4 AREAS OF 2ND DEGREE BURNS, THE LARGEST <4MM IN DIAMETER. ALL WOUNDS WERE HEALING WELL. EMPI COMPANY HAS BEEN NOTIFIED OF THIS EVENT.