HYBRESIS

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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT RECEIVED A 3RD DEGREE BURN DURING AN IONTOPHORESIS TREATMENT ON THE BACK OF THE LEFT HEEL/ANKLE AREA. PATIENTS' DIAGNOSIS IS LEFT ACHILLES TENDONITIS. THE TREATMENT DATE WAS (B)(6) 2014 AND THIS WAS THE SEVENTH TREATMENT WITH THE IONTOPHORESIS PATCH. THE COMPOUND USED WAS DEXAMETHASONE, CONCENTRATION WAS 0.4%. THE AMOUNT USED WAS APPROXIMATELY 1.3ML. THE COMPOUND WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND SALINE SOLUTION WAS ADDED TO THE POSITIVE SIDE OF THE PATCH. THE SKIN WAS PREPARED WITH ALCOHOL. THE MODE WAS HYBRESIS 80MA/MIN AND THE PATCH WAS WORN FOR 2 HOURS. THE PATCH WAS APPLIED TO THE PATIENT BY A HEALTH PROFESSIONAL. THE TREATMENT AREA WAS COMPRESSED, THE PATIENT PUT HER SOCK AND SHOE ON AFTER THE TREATMENT PATCH WAS APPLIED. THE CLINIC STATED THAT OVER A PERIOD OF VISITS THE PAD PLACEMENT WAS ADJUSTED TO ASSURE THERE WAS AS MINIMAL PRESSURE FROM SHOE, BUT ALSO COVERING AND TREATING THE PAINFUL AREA. PATIENT FELT MORE IRRITATION THAN NORMAL AFTER SHE LEFT THE CLINIC AND THEN FOR LONGER THAN NORMAL AFTER REMOVING THE PATCH. THE IRRITATION WAS UNDER THE NEGATIVE SIDE OF THE PATCH. THE BURN LOOKS LIKE A CIGARETTE BURN, BLACK IN COLOR AND WAS DIAGNOSED BY THE CLINIC TO BE A THIRD DEGREE BURN. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THE INCIDENT, AND PROGRESS TOWARD RECOVER WAS NOT IMPEDED BECAUSE OF THIS INCIDENT.