HYBRESIS
Received Jul 15, 2010 · Event occurred Jun 22, 2010
Report 1721293-2010-00005 · MDR key 1764947
Device
Product problems
- Insufficient Device Problem Information
Patient
68 YR
- Necrosis
- Burn, Thermal
Narrative
Description of Event or Problem
IT WAS REPORTED TO EMPI THAT A FEMALE PATIENT WAS BURNED WHILE WEARING THE HYBRESIS PATCH. THE TREATMENT WAS FOR TENDINITIS/BURSITIS ON THE RIGHT PATELLA. THE PATIENT FELT BURNING WHILE WEARING THE PATCH, AND DID NOT REMOVE FOR 2.5 HOURS. THE BURN WAS UNDER THE BATTERY AREA OF THE BATCH. THE BURN WAS REPORTED TO BE APPROXIMATELY THE SIZE OF A CIGARETTE BURN WITH BLACK NECROTIC TISSUE AND NO DISCHARGE.
Additional Manufacturer Narrative
THE PATCH WAS NOT RETURNED TO EMPI FOR EVALUATION. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.