ANODYNE THERAPY

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE OUTER LEFT CALF, MEASURING APPROX 1" X 1/2", FOLLOWING TREATMENT WITH THE ANODYNE HOME UNIT WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PT WAS TREATED WITH A TOPICAL ANTIBIOTIC OINTMENT AND IS HEALING.

Additional Manufacturer Narrative

PT WAS BEING TREATED WITH THE ANODYNE UNIT FOR NEUROPATHY AND A WOUND. THE TREATING FACILITY REPORTS TO HAVE TREATED ACCORDING TO THE RECOMMENDED TREATMENT TIME FOR NEUROPATHY (45 MINUTES), AND SHOULD HAVE TREATED ACCORDING TO THE RECOMMENDED TREATMENT TIME FOR A WOUND (30 MINUTES). THIS RECOMMENDED TREATMENT TIME IS OUTLINED IN THE SAFETY INFO AND INSTRUCTION MANUAL THAT IS SUPPLIED WITH ALL UNITS. THE PT BEING TREATED REPORTED A BURNING SENSATION TO THE TREATING HEALTH CARE PROFESSIONAL. INSTEAD OF REDUCING THERAPY TIME, AS PER CAUTIONS PROVIDED IN THE SAFETY AND INSTRUCTION MANUAL, THE HEALTH CARE PROFESSIONAL DID NOT RESPOND TO THE PT. WE HAVE REQUESTED THE UNITS INVOLVED BE RETURNED FOR EVAL. THEY HAVE NOT YET BEEN REC'D, AND SO NO EVAL REPORT IS AVAILABLE AT THIS TIME. 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.