HYBRESIS
Received Oct 6, 2010 · Event occurred Apr 26, 2010
Report 1721293-2010-00013 · MDR key 1867742
Device
Product problems
- Insufficient Device Problem Information
Patient
50 YR
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A PT WAS BURNED DURING A HYBRESIS TREATMENT. THE TREATMENT WAS THE 9TH TREATMENT FOR KNEE PAIN. THE COMPOUND USED WAS 4 MG/ML OF DEXAMETHASONE 1.5 ML ON THE NEGATIVE SIDE AND SALINE ON THE POSITIVE SIDE OF THE PATCH. THE TREATMENT WAS FOR 1.5 HOURS IN THE HYBRESIS MODE. THE BURN WAS UNDER THE CENTER OF THE PATCH BY THE BATTERIES. THE BURN WAS 2 CM ROUND AND PT WENT TO THE EMERGENCY ROOM. NO MEDICATION WAS GIVEN TO THE PT.
Additional Manufacturer Narrative
THE PATCH ASSOCIATED WITH THE BURN WAS RETURNED ALONG WITH 5 UNUSED PATCHES FROM THE SAME BOX. THE HYBRESIS CONTROLLER WAS ALSO RETURNED. THE CONTROLLER AND THE UNUSED ELECTRODES MET ELECTRICAL AND PHYSICAL SPECIFICATIONS. THE USED ELECTRODE HAD A NICK IN THE FLEX CIRCUIT THAT COULD HAVE CONTRIBUTED TO THE BURN. THE PATCH WAS USED APPROX ONE YR AFTER THE EXP DATE. 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.