HYBRESIS
Received Jul 6, 2010 · Event occurred May 26, 2010
Report 1721293-2010-00003 · MDR key 1758252
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Necrosis
- Superficial (First Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
TWO OPENED HYBRESIS ELECTRODES WERE RETURNED TO EMPI. THE RETURNED ELECTRODES WERE USED AND FOLDED IN HALF. THERE WAS A NICK IN THE FLEX CIRCUIT ON ONE OF THE RETURNED HYBRESIS PATCHES. THE OTHER PATCH CIRCUIT WAS INTACT. THE NICK IN THE FLEX CIRCUIT COULD HAVE CONTRIBUTED TO A BURN TO THE PT.
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PT WAS BURNED USING A HYBRESIS PATCH. PRIOR TO THE HYBRESIS TREATMENT, THE PT RECEIVED A PHONOPHORESIS TREATMENT. THE PT RECEIVED 2 SEPARATE 3 MINUTE TREATMENTS WITH THE HYBRESIS PATCH. ONE TREATMENT WAS ON THE LEFT TIBIALIS ANTERIOR TENDON, AND THE SECOND TREATMENT WAS ON THE LEFT TIBIALIS POSTERIOR TENDON. BOTH TREATMENTS USED THE COMPOUND DEXAMETHASONE ON THE NEGATIVE SIDE OF THE PATCH AND SALINE SOLUTION ON THE POSITIVE SIDE OF THE PATCH. THE TREATMENT WAS FOR 3 MINUTES IN HYBRESIS MODE AND THE PT WAS INSTRUCTED TO WEAR FOR 2 HOURS AT HOME THEN REMOVE. WHEN THE PT REMOVED THE PATCH, THE BURN WAS UNDER THE BATTERY AREA OF THE PATCH ON THE ANTERIOR SIDE OF THE TENDON. THE PT'S TREATMENTS NOTES INDICATED THAT THE BURN WAS FIRST DEGREE, WITH WHITE NECROTIC TISSUE ON THE PERIMETER, AND BLACK NECROTIC ESCHAR TISSUE IN THE CENTER AND APPROXIMATELY .5 CM AREA. THE PT WAS SUTURED AT BURN AREA.