ANODYNE THERAPY

Description of Event or Problem

TREATING FACILITY REPORTS A PATIENT DEVELOPED A BURN WITH BLISTERS APPROXIMATELY 1/2" X 1/2" AND A REDDENED AREA 5CM X 2CM ON THE CALF FOLLOWING AN ANODYNE THERAPY TREATMENT. REPORTED PATIENT INJURY HAS COMPLETELY HEALED.

Additional Manufacturer Narrative

THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AFTER PATIENT REPORTEDLY DEVELOPED A 2ND DEGREE BURN WITH BLISTERS APPROXIMATELY 1/2 X 1/2" AND A REDDENED AREA APPROXIMATELY 5CM X 2CM ON THE LE CALF FOLLOWING TREATMENT WITH AN ANODYNE THERAPY PROFESSIONAL SYSTEM. PATIENT SELF ADMINISTERED SILVADENE, AND DID RECEIVE MEDICAL INTERVENTION OF A TOPICAL ANTIBIOTIC. REPORTED TREATMENT TIME AND INTENSITY WAS WITHIN THE GUIDELINES PROVIDED TO THE USER IN THE IFU MANUAL. EVALUATION IDENTIFIED A BROKEN WIRE IN ONE THERAPY PAD, AND A BAD CONNECTION IN ONE JACK, NEITHER OF WHICH WOULD BE EXPECTED TO CAUSE HIGH TEMPERATURES. ADDITIONALLY, DURING SIMULATED USE, THE THERAPY PAD TEMPERATURES WERE FOUND TO BE WELL WITHIN LEVELS THAT WOULD NOT BE EXPECTED TO CAUSE A BURN. THE FACILITY REPORTED THAT THEY USED THIS SAME ANODYNE UNIT ON VARIOUS OTHER PATIENTS AROUND THE SAME TIME AS THE REPORTED INJURY WITHOUT INCIDENT. ACCORDINGLY, ANODYNE IS NOT ABLE TO CONFIRM THAT THIS ANODYNE UNIT CAUSED THE REPORTED INJURY. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY CONTINUES TO MONITOR AND TREND EVENTS OF THIS TYPE.