HYBRESIS

Description of Event or Problem

IT WAS REPORTED TO EMPI THAT A PATIENT RECEIVED A 3RD DEGREE BURN DURING A HYBRESIS TREATMENT. THE INJURY WAS ON THE ANTERIOR LEFT SHOULDER, THE DIAGNOSIS WAS S/P RTC REPAIR; BICEPS TENDONITIS. THIS WAS THE 2ND TREATMENT. THE SKIN WAS CLEANED WITH ALCOHOL PRIOR TO THE TREATMENT. THE COMPOUND USED WAS DEXAMETHASONE AT 0.4% CONCENTRATION AND 1.5ML WAS USED ON THE NEGATIVE SIDE OF THE HYBRESIS PATCH. THE MODE WAS HYBRESIS AND THE TREATMENT WAS FOR 2 HOURS FOR 80MA MINUTE. THE THERAPY PERFORMED PRIOR TO THE TREATMENT WAS, THERAPEUTIC EXCERCISE, MANUAL THERAPY TO INCLUDE SOFT TISSUE, JOINT MOBILIZATION AND PROM (PASSIVE RANGE OF MOTION). THE TREATMENT AREA WAS NOT COMPRESSED AND THERE WAS NO WRAP OR COVERING ON THE ELECTRODE. THE PATIENT NOTICED THE BURN UPON REMOVAL OF THE PATCH AND THE PHYSICAL THERAPIST WAS NOTIFIED. THE BURN WAS UNDER THE NEGATIVE SIDE OF THE PATCH. THERE WAS DISCOMFORT, PAIN AND REDNESS AROUND THE AREA OF THE BURN. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INCIDENT. PROGRESS TOWARD RECOVERY WAS NOT IMPEDED BECAUSE OF THIS INCIDENT. THE PATIENT HAS NOT EXPERIENCED THIS TYPE OF ISSUE WITH THE HYBRESIS PATCH BEFORE.

Additional Manufacturer Narrative

THE HYBRESIS PATCH THAT WAS USED WILL NOT BE RETURNED FOR EVALUATION. IF MORE INFORMATION BECOMES AVAILABLE THEN A FOLLOW-UP REPORT WILL BE FILED. PATCH WAS DISCARDED BY PATIENT.