ANODYNE THERAPY

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN ON HIS RIGHT CALF, APPROXIMATELY 8 CM X 1 CM, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PT REC'D MEDICAL INTERVENTION AND WAS TREATED WITH LACTOFERRIN, AND IS HEALING.

Additional Manufacturer Narrative

THE UNIT INVOLVED IN THIS EVENT HAS BEEN RETURNED FOR EVALUATION, AND WAS FOUND TO BE OPERATING WITHIN SPECIFICATIONS AND TEMPERATURE GUIDELINES. THE REPORTING FACILITY WAS TREATING THE PT FOR DIABETIC PERIPHERAL NEUROPATHY. THEY REPORTED TREATING THE PT AT AN ENERGY SETTING OF 10, WHICH EXCEEDS THE RECOMMENDED SETTING PROVIDED IN OUR IMPORTANT INSTRUCTION AND SAFETY MANUAL PROVIDED WITHOUT UNITS. THE PT HAD REC'D 12 PRIOR TREATMENTS WITH THE ANODYNE THERAPY SYSTEM, ALL WITHOUT INCIDENT. 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 PTS AND CLINICIANS TO HEED THE WARNINGS AND TO FOLLOW THE ADEQUATE DIRECTIONS FOR USE THAT ACCOMPANY THE DEVICE.