ANODYNE THERAPY

Additional Manufacturer Narrative

WE HAVE REQUESTED THE CUSTOMER RETURN THIS UNIT TO US FOR EVALUATION: BUT IT HAS NOT YET BEEN RECEIVED. THE TREATING FACILITY REPORTS TREATING THIS PT FOR SHOULDER PAIN FOR THE FIRST TIME WITH ANODYNE THERAPY. THEY REPORT TREATING FOR 15 MINS AND AT AN ENERGY SETTING OF 8; WHICH IS WITHIN THE TREATMENT GUIDELINES FOR THIS CONDITION. 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.

Description of Event or Problem

PT IS REPORTED TO HAVE DEVELOPED A BURN, APPROX 2 7/8" X 4 5/8", ON THE INFERIOR LEFT SHOULDER FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. TREATMENT WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PT WAS TREATED WITH SILVADENE CREAM BY THE STAFF AT THE REHABILITATION CLINIC. PT HAS COMPLETELY HEALED.