ANODYNE THERAPY

Description of Event or Problem

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN AFTER FALLING ASLEEP DURING TREATMENT WITH THE ANODYNE THERAPY HOME SYSTEM. THE BURN MEASURED APPROXIMATELY 1 1/4" IN DIAMETER AND WAS LOCATED ON THE BACK OF THE LEG JUST ABOVE THE ANKLE. THE PATIENT HAS RECEIVED MEDICAL INTERVENTION, BEING TREATED WITH ANTIBIOTICS.

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 WITH THE UNIT TUNRED ON, AND REALIZED HIS ERROR. CUSTOMER REPORTED HE HAD USED THE SYSTEM MULTIPLE TIMES PREVIOUSLY, ALL WITHOUT INCIDENT. THE UNIT INVOLVED IN THIS EVENT HAS BEEN RETURNED FOR EVALUATION, AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS AN TEMPERATURE GUIDELINES. 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 PATIENT'S AND CLINICIANS TO HEED THE WARNINGS AND TO FOLLOW THE ADEQUATE DIRECTIONS FOR USE THAT ACCOMPANY THE DEVICE.