HYBRESIS

Additional Manufacturer Narrative

THE SUSPECT PATCH WAS NOT RETURNED TO EMPI FOR EVAL. HOWEVER, OTHER PRODUCTS FROM THE CUSTOMER'S SITE WERE EVALUATED. TWENTY-EIGHT SAMPLE PATCHES FROM 15 LOTS WERE EVALUATED. TWO SAMPLES HAD BATTERY VOLTAGES SLIGHTLY LOWER THAN SPECIFIED. OF THE TWO PATCHES THAT DID NOT MEET ELECTRICAL SPECS, ONE HAD THE HYBRESIS PATCH MISALIGNED WHEN ASSEMBLED, AND THE OTHER HAD THE LOWER VOLTAGE ON THE BATTERY BUT WAS ASSEMBLED CORRECTLY. THE OTHER RETURNED PATCHES TESTED ALL MET PHYSICAL AND ELECTRICAL SPECS. NEITHER OF THE TWO FAILURES WOULD BE EXPECTED TO CONTRIBUTE TO THE INJURY. 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.

Description of Event or Problem

IT WAS REPORTED TO EMPI THAT A FEMALE PT WAS BURNED WHILE WEARING THE HYBRESIS PATCH. THE TREATMENT WAS FOR ANKLE TENDONITIS OF THE PERONEAL TENDON. IT WAS THE PT'S EIGHTH TREATMENT WITH THE HYBRESIS PATCH. DEXAMETHASONE WAS USED ON THE NEGATIVE PAD AND THE HYBRESIS MODALITY WAS USED. THE PT NOTICED INCREASED SENSATION AFTER THE CONTROLLER WAS REMOVED AND DID NOT REMOVE THE PATCH. AFTER 2 HOURS THE PT REMOVED THE PATCH AND NOTICED A BLACK HOLE UNDER THE BATTERY COMPARTMENT. SHE DID NOT REPORT THE BURN TO THE CLINIC AT THE TIME. THE PT WAS REFERRED TO HER PRIMARY PHYSICIAN FOR TREATMENT. AN ANTIBIOTIC WAS PRESCRIBED.