HYBRESIS
Received Jan 4, 2011 · Event occurred Oct 20, 2010
Report 1721293-2010-00020 · MDR key 1952443
Device
Product problems
- Thermal Decomposition of Device
Patient
31 YR
- No Known Impact Or Consequence To Patient
Narrative
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 THAT IT COULD HAVE CONTRIBUTED TO THIS INJURY.
Description of Event or Problem
IT WAS REPORTED THAT A PT SUFFERED A BURN UNDER THE BATTERY AREA OF THE HYBRESIS PATCH. THE PT WAS BEING TREATED FOR S/P NERVE TRANSPOSITION, USING DEXAMETHASONE 1.5CC, CONCENTRATION 4MG/ML. THE TREATMENT TIME WAS 2 HOURS. THE PT DID NOT REQUIRE ANY SPECIAL ATTENTION FOR THE BURN.