ANODYNE THERAPY

Description of Event or Problem

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN AFTER FALLING ASLEEP FOR SEVERAL HOURS, DURING A TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. THE BURN MEASURED APPROXIMATELY 3 X 4CM, AND IS LOCATED ON THE BACK OF THE WRIST. THE PATIENT HAS RECEIVED MEDICAL INTERVENTION, AND IS BEING TREATED WITH SILVADENE, AND IS HEALING.

Additional Manufacturer Narrative

USER REPORTED THAT THEY DID NOT OPERATE THE UNIT IN ACCORDANCE WITH SAFETY GUIDELINES. THE SAFETY AND INFORMATION MANUAL PROVIDED WITH EACH UNIT CAUTIONS USERS NOT TO SLEEP WITH THE THERAPY PADS TURNED ON, AS THIS MAY CAUSE BURNS. USER FELL ASLEEP FOR "SEVERAL HOURS" WITH THE UNIT TURNED ON, AND REALIZED HER ERROR. CUSTOMER REPORTED, SHE HAD USED THE SYSTEM APPROXIMATELY 40 TIMES PREVIOUSLY, ALL WITHOUT INCIDENT. WE HAVE REQUESTED THAT THE CUSTOMER RETURN THE UNIT TO US FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED. THE DESIGN AND FUNCTIONALITY OF ANODYNE'S DEVICE DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN OUR MDR'S. THE DIRECTIONS FOR USE AND WARNINGS THAT ACCOMPANY THE DEVICE ARE ADEQUATE FOR PURPOSES OF PREVENTING THERMAL INCIDENTS. WE BELIEVE THAT MOST OF THE REPORTED EVENTS HAVE RESULTED FROM THE ISOLATED FAILURE OF PATIENTS AND CLINICIANS TO HEED THE WARNINGS AND TO FOLLOW THE ADEQUATE DIRECTIONS FOR USE THAT ACCOMPANY THE DEVICE.