HYBRESIS
Received Oct 6, 2010 · Event occurred Mar 1, 2010
Report 1721293-2010-00011 · MDR key 1867746
Device
Product problems
- Overheating of Device
Patient
Not reported
- Burn(s)
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 POST TIB TENDONITIS. DEXAMETHASONE AT 1.25ML WAS USED ON THE NEGATIVE SIDE, AND SALINE ON THE POSITIVE SIDE. THE PATCH WAS WORN FOR 2 HOURS AND THE PT DESCRIBES THE BURNING AS INTERMITTENT. THE BURN WAS 4MM IN DIAMETER AND RED WITH ESCHAR. NO MEDICAL INTERVENTION WAS REQUIRED.
Additional Manufacturer Narrative
NO PRODUCT RETURNED. 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.