HYBRESIS

Description of Event or Problem

THE FOLLOWING INFORMATION WAS REPORTED TO EMPI: A PATIENT RECEIVED A 3RD DEGREE BURN TO HIS UPPER LEFT ARM, WITH RESULTING SCARRING. THE BURN WAS UNDER THE NEGATIVE POLARITY OF THE PATCH. THE MODE USED WAS HYBRESIS. THE PATIENT EXPERIENCED PAIN ALMOST FROM THE BEGINNING OF THE TREATMENT. A WRAP OR COVERING WAS PLACED OVER THE ELECTRODE, BUT THE TREATMENT AREA WAS NOT COMPRESSED. THE PATIENT DID RECEIVE MEDICAL TREATMENT FOR THE INCIDENT, AND PROGRESS TOWARDS RECOVERY WAS IMPEDED. AFTER THE PATCH WAS REMOVED, A BURN MARK WAS VISIBLE ON THE UNDERSIDE OF THE PATCH CLOSER TO THE NEGATIVE ELECTRODE.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS NOT RETURNED TO EMPI FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE. A REVIEW OF THE HYBRESIS USER MANUAL WAS PERFORMED. IT STATES: "ADVISE THE PATIENT TO REPORT IMMEDIATELY ANY PAIN DURING TREATMENT. IF THE PATIENT COMPLAINS OF PAIN, PAUSE THE TREATMENT, INSPECT THE AREA UNDER THE PATCH AND MAKE NECESSARY ADJUSTMENTS (E.G. REPOSITION THE PATCH TO ENSURE FULL SKIN CONTACT, DECREASE CURRENT, ETC.) BEFORE RESUMING THE TREATMENT OR DISCONTINUE THE TREATMENT." "DO NOT TAPE OR BIND THE PATCH DURING TREATMENT." A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO ISSUES WERE FOUND. DEVICE NOT RETURNED.