ANODYNE THERAPY

Additional Manufacturer Narrative

TREATING FACILITY REPORTED THAT THIS PATIENT HAD BEEN TREATED FOR 45 MINUTES AT AN ENERGY SETTING OF 10 WHICH EXCEEDS THE GUIDELINE PROVIDED IN THE IMPORTANT SAFETY AND INFORMATION MANUAL PROVIDED TO THE FACILITY. FACILITY HAS BEEN RETRAINED ON THE PROPER USE OF THE SYSTEM. WE HAVE REQUESTED THAT THIS UNIT BE RETURNED FOR EVALUATION, BUT HAS NOT YET BEEN RECEIVED. 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 PATIENTS 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 CALF, APPROXIMATELY 1/4" X 1/4", FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. THE PATIENT HAS BEEN TREATED WITH SILVADENE, AND HAS HEALED.