HYBRESIS
Received Nov 30, 2012 · Event occurred Oct 4, 2012
Report 1721293-2012-00007 · MDR key 2853151
Device
Product problems
- Overheating of Device
Patient
68 YR
- Burn(s)
- Irritation
- Pain
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED DURING A HYBRESIS TREATMENT. THE PATIENT WAS DIAGNOSED WITH RIGHT KNEE PAIN. THE THERAPY PERFORMED BEFORE THE TREATMENT WAS MASSAGE AND THERAPEUTIC EXERCISE. THE COMPOUND USED WAS DEXAMETHAXONE, 1.4ML CONCENTRATION WAS 0.4%. THE COMPOUND WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND SALINE WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE HYBRESIS TREATMENT WAS FOR TWO HOURS AND IN HYBRESIS MODE. THE PATIENT NOTICED IRRITATION, BURNING AND STINGING WITHIN THE FIRST HOUR INTO THE TREATMENT, BUT LEFT THE PATCH ON FOR TWO HOURS. THE DEGREE OF BURN WAS SECOND DEGREE, AND UNDER THE BATTERY AREA OF THE PATCH. THE PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR THIS INCIDENT.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. 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 COULD HAVE CONTRIBUTED TO THIS INJURY. PATCH DISGARDED BY USER.