ANODYNE THERAPY

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE INNER SIDE OF THE SHIN ON THE LEFT LEG FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE BURN MEASURED APPROX 2" X 1". AT THE ADVICE OF HIS PHYSICAL THERAPIST, THE PT TREATED THE BURN WITH SILVADENE, AND IS HEALING.

Additional Manufacturer Narrative

PT WAS BEING TREATED WITH THE ANODYNE PROFESSIONAL SYSTEM FOR A WOUND. THE TREATING FACILITY REPORTS TREATING FOR 45 MINS, WHICH EXCEEDS THE RECOMMENDED TREATMENT GUIDELINES FOR THIS CONDITION. THE UNIT INVOLVED IN THIS EVENT WAS RETURNED FOR EVAL. VOLTAGE AND FREQUENCY WERE TESTED, AND READINGS VERIFIED THE UNIT WAS OPERATING WITHIN SPECS. A FREE AIR TEST WAS CONDUCTED ON THE ARRAYS OF THIS UNIT, AND 6 ARRAYS WERE FOUND TO BE OPERATING WITHIN TEMPERATURE GUIDELINES. DEFECTIVE WIRES WERE FOUND ON 2 ARRAYS WHICH CAUSED NO POWER TO REACH THE LED'S, AND SO WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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.