ANODYNE THERAPY

Additional Manufacturer Narrative

REPORTING FACILITY WAS TREATING THE PT FOR A WOUND. THE TREATMENT TIME THEY REPORTED EXCEEDS THE RECOMMENDED TREATMENT TIME PROVIDED IN THE SAFETY INFO AND INSTRUCTION MANUAL. THE PATIENT HAD REC'D 4 PRIOR TREATMENTS WITHOUT INCIDENT. THE UNIT INVOLVED IN THE EVENT HAS BEEN RETURNED FOR EVALUATION. VOLTAGE AND FREQUENCY WERE TESTED AND CONFIRMED THE UNIT WAS OPERATING WITHIN SPECIFICATIONS. TEMPERATURE TESTS WERE CONDUCTED ON THE THERAPY PADS OF THE UNIT, AND WERE FOUND TO BE OPERATING WITHIN TEMPEATURE GUIDELINES. THE DESIGN AND FUNCITONALITY 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 RESULTEDS 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

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE LEFT SIDE OF HIS COCCYX, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE BURN MEASURED APPROXIMATELY 2" X 1 1/2". PATIENT'S NURSE PRESCRIBED SILVADENE AND DURASKIN.