ANODYNE THERAPY

Additional Manufacturer Narrative

TREATING FACILITY REPORTED THAT THIS PATIENT WAS BEING TREATED BY A RELIEF NURSE WHO THEY REPORTED HAD NOT OPERATED THE UNIT IN ACCORDANCE WITH SAFETY GUIDELINES. SHE HAD TREATED THIS PATIENT'S CONDITION FOR 45 MINUTES AT AN ENERGY SETTING OF 10 WHICH EXCEEDS THE GUIDELINE PROVIDED IN THE IMPORTANT SAFETY AND INFORMATION MANUAL PROVIDED WITH EACH UNIT. WE HAVE REQUESTED THAT THE CUSTOMER RETURN THE UNIT TO US FOR EVALUATION, BUT IT 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

PT IS REPORTED TO HAVE DEVELOPED A BURN ON THE KNUCKLE OF THE 1ST FINGER OF THE LEFT HAND AND ANOTHER JUST BELOW HER KNEE. THIS OCCURRED FOLLOWING TREATMENT WITH THE ANODYNE THERAPY SYSTEM, ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE PT WAS TREATED WITH TRIPLE ABX AND SILVADENE AND HAS HEALED.