ANODYNE THERAPY

Description of Event or Problem

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON THE BOTTOM OF THE LEFT FOOT, MEASURING APPROXIMATELY 6CM X 6CM, FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL UNIT WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH DRESSINGS AND BATHS. PATIENT WAS RELEASED AFTER ONE WEEK, AND IS HEALING.

Additional Manufacturer Narrative

PATIENT WAS BEING TREATED WITH THE ANODYNE UNIT FOR A WOUND AND DIABETIC PERIPHERAL NEUROPATHY. THE TREATING FACILITY REPORTS TO HAVE TREATED ACCORDING TO THE RECOMMENDED TREATMENT GUIDELINES FOR THESE CONDITIONS. WE HAVE REQUESTED THE UNIT INVOLVED BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED, AND SO NO EVALUATION 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 WARNIGS 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.