MalfunctionEGJ
HYBRESIS
Received Oct 6, 2010 · Event occurred Mar 9, 2009
Report 1721293-2010-00007 · MDR key 1867752
Device
Product problems
- Insufficient Device Problem Information
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 BURN WAS APPROX 1 CM IN DIAMETER AND UNDER THE BATTERY AREA OF THE PATCH. THE BURN WAS TREATED WITH HYDROCORTISONE DRESSING AND SILVADENE OINTMENT.
Additional Manufacturer Narrative
THE PATCH WAS NOT RETURNED TO EMPI FOR EVAL. 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.