ANODYNE THERAPY

Additional Manufacturer Narrative

REPORTING FACILITY REPORTS TREATING PATIENT AT THE RECOMMENDED TREATMENT TIME AND SETTING FOR THE PATIENT'S CONDITION. THE PATIENT HAD RECEIVED 23 PRIOR TREATMENTS WITHOUT INCIDENT. H6: METHOD: 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 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 LEFT AND RIGHT CALF, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE BURNS MEASURED APPROXIMATELY 1.9CM X2.2CM AND 3.2CM X3.1CM RESPECTIVELY. PATIENT'S DOCTOR PRESCRIBED ANTIBIOTICS AND HOME HEALTH WOUND CARE; PATIENT IS HEALING.