HYBRESIS

Description of Event or Problem

IT WAS REPORTED TO EMPI THAT A PATIENT RECEIVED A BURN UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PATIENT WAS DIAGNOSED WITH ACHILLES TENDONITIS. THE COMPOUND USED WAS DEXAMETHASONE NAPO4 4MG/ML, WHICH WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH. SALINE WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE THERAPY PERFORMED PRIOR TO THIS TREATMENT WAS ASTYM TO THE LOWER EXTREMITY. THE TREATMENT MODE USED WAS HYBRESIS, LASTING 2 HOURS. A WRAP OR COVERING WAS PLACED OVER THE PATCH, BUT IT WAS NOT COMPRESSED. THE PATIENT RATED THE PAIN AT 2/10 AND DESCRIBED IT AS STINGING, BUT NOTHING THAT MADE HIM WANT TO STOP THE TREATMENT EARLY. THE BURN WAS NOTED WHEN THE PATCH WAS REMOVED. THE BURN WAS THE SIZE OF A PENCIL ERASER. THE CLINIC REPORTED THIS TO BE A FIRST DEGREE BURN AND THAT NO MEDICAL INTERVENTION WAS NEEDED. THE PATCH WAS DISCARDED AFTER USE.

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THIS REPORT IS BEING SUBMITTED BECAUSE EMPI HAS RECEIVED A SIMILAR COMPLAINT THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. PATCH WAS DISCARDED BY USER FACILITY.