HYBRESIS
Received Oct 6, 2010 · Event occurred Dec 7, 2009
Report 1721293-2010-00008 · MDR key 1867751
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Necrosis
- Pain
- Discomfort
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PT WAS BURNED DURING A HYBRESIS TREATMENT. THE PT WAS BEING TREATED FOR ACHILLES TENDONITIS WITH DEXAMETHOSONE 1.5 ML SODIUM PHOSPHATE. THE PT EXPERIENCED DISCOMFORT, AND A SHARP PAIN ON THE NEGATIVE SIDE OF THE PATCH UNDER THE BATTERY PACK. THE PT SEEN THE BURN IMMEDIATELY AFTER REMOVING THE PATCH, BUT DID NOT CALL THE PHYSICAL THERAPIST DEPT UNTIL 4:45 PM. THE BURN WAS SMALL, BLACK NECROSIS IN THE CENTER. THE PT THREW THE PATCH AWAY AFTER THE TREATMENT.
Additional Manufacturer Narrative
THE HYBRESIS PATCH WAS NOT RETURNED TO EMPI FOR EVAL. THREE DOSE CONTROLLERS AND ONE CHARGER WERE RETURNED. THE THREE DOSE CONTROLLERS AND THE CHARGING STATION ALL MET ELECTRICAL AND PHYSICAL REQUIREMENTS. 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.