HYBRESIS
Received Oct 5, 2010 · Event occurred Feb 8, 2010
Report 1721293-2010-00012 · MDR key 1865403
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
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 BILATERAL CARPAL TUNNEL SYNDROME. THE COMPOUND WAS DEXAMETHASONE SODIUM PHOSPHATE, 1.5CC ON THE NEGATIVE SIDE OF THE PATCH AND SALINE ON THE POSITIVE SIDE OF THE PATCH. THE TREATMENT WAS FOR 4 HOURS USING THE HYBRESIS MODE. THE PT WAS INSTRUCTED TO REMOVE THE PATCH IF SHE HAD ANY DISCOMFORT. THE PT CALLED THE CLINIC THE NEXT DAY STATING THAT SHE WAS BURNED BY THE PATCH ON HER LEFT WRIST. THE BURN WAS UNDER THE CENTER OF THE PATCH WHERE THE PT NOTICED AN EXPOSED WIRE. THE BURN WAS REDRESSED WITH A BAND-AID AND WAS NOT INFECTED.
Additional Manufacturer Narrative
THE PATCH WAS RECEIVED FOR INVESTIGATION. THE ELECTRODE DID NOT MEET PHYSICAL OR ELECTRICAL SPECIFICATION, AS THE FLEX CIRCUIT WAS CUT. THIS REPORT IS BEING SUBMITTED BECAUSE EMPI HAS RECEIVED A SIMILAR COMPLAINT THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY IT COULD HAVE CONTRIBUTED TO THIS INJURY.