HYBRESIS
Received Aug 23, 2010 · Event occurred May 25, 2010
Report 1721293-2010-00014 · MDR key 1816492
Device
Product problems
- Insufficient Device Problem Information
Patient
39 YR
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT WAS BURNED UNDER THE BATTERY AREA OF THE HYBRESIS ELECTRODE PATCH. THE BURN WAS APPROX 1/2 CM. THE PT WAS BEING TREATED FOR BILATERAL CARPAL TUNNEL SYNDROME. THE COMPOUND THAT WAS USED IS DEXAMETHASONE AT A CONCENTRATION OF 4MG/ML. THE DEXAMETHASONE WAS PLACED ON THE NEGATIVE SIDE OF THE PATCH AND THE SALINE WAS PLACED ON THE POSITIVE SIDE OF THE PATCH. THE TREATMENT LASTED FOR 3 MINUTES IN HYBRESIS MODE AND THE ELECTRODE PATCH WAS WORN FOR 2 HOURS. THE PT EXPERIENCED DISCOMFORT BUT DID NOT REMOVE THE PATCH. PRIOR TO THE HYBRESIS TREATMENT, FLUIDOTHERAPY WAS PERFORMED.
Additional Manufacturer Narrative
NO PRODUCT RETURNED. 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.