ANODYNE THERAPY

Description of Event or Problem

TREATING FACILITY REPORTS A PT DEVELOPED A BURN THE SIZE OF A QUARTER ON THE CALF FOLLOWING AN ANODYNE THERAPY TREATMENT.

Additional Manufacturer Narrative

THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVAL AFTER PT REPORTEDLY DEVELOPED A 2ND DEGREE BURN THE SIZE OF A QUARTER ON THE RT CALF FOLLOWING TREATMENT WITH AN ANODYNE THERAPY PROFESSIONAL SYSTEM. PT DID RECEIVED MEDICAL INTERVENTION - A TOPICAL ANTIBIOTIC. REPORTED TREATMENT TIME AND INTENSITY WAS WITHIN THE GUIDELINES PROVIDED TO THE USER IN THE IFU MANUAL. UPON EVAL, A DEFECTIVE TRANSISTOR WAS IDENTIFIED; HOWEVER, THERAPY PAD TEMPERATURES DURING SIMULATED USE WERE FOUND TO BE WILL WITHIN LEVELS THAT WOULD NOT BE EXPECTED TO CAUSE A BURN. ADDITIONALLY, THE FACILITY REPORTED THEY USED THIS SAME ANODYNE UNIT ON OTHER PTS WITHOUT INCIDENT AROUND THE SAME TIME AS THE REPORTED INJURY. 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.