HYBRESIS
Received Oct 1, 2012 · Event occurred Jul 17, 2012
Report 1721293-2012-00005 · MDR key 2766063
Device
Product problems
- Insufficient Device Problem Information
Patient
39 YR
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PATIENT WAS BURNED UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PATIENT WAS BEING TREATED FOR TENSYNOVITIS OF ECRB/ECRL, RADIAL STYLOID, TRAPEZIUM SCAPHOID. THE COMPOUND USED WAS DEXAMETHASONE, 1.5 CC AND CONCENTRATION WAS .4%. THE DEXAMETHASONE WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND SALINE SOLUTION WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE MODE USED WAS HYBRESIS AND THE PATCH WAS WORN FOR TWO HOURS. THE PATIENT DID NOT FEEL PAIN OR DISCOMFORT DURING THE THERAPY. WHEN THE PATCH WAS REMOVED THE PATIENT SAW A DARK CIRCLE UNDER THE BATTERY AREA OF THE PATCH. THIS WAS A SECOND DEGREE BURN. THE PATIENT RECEIVED BASIC FIRST AID FOR THE BURN/WOUND.
Additional Manufacturer Narrative
THE INVESTIGATION SHOWED THAT THERE WAS A BREAK IN THE DIELECTRIC LAYER COVERING THE CONDUCTIVE TRACE IN THE FLEX CIRCUIT. THIS DEFECT COULD HAVE CAUSED THIS INJURY. THIS INCIDENT IS SIMILAR TO A COMPLAINT RECEIVED BY EMPI THAT SUGGESTS THAT THIS DEVICE MAY HAVE MALFUNCTIONED IN SUCH A WAY THAT IT COULD CAUSE A SERIOUS INJURY.