ANODYNE THERAPY

Additional Manufacturer Narrative

PT IS REPORTED TO HAVE DEVELOPED A 2ND DEGREE BURN ON THE CALF FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL MODEL. THE TREATING FACILITY REPORTS TREATING THE PT AT A HIGHER INTENSITY THAN SUGGESTED AND ON THE TOP OF THE FOOT WHICH IS AN UNINTENDED TREATMENT LOCATION AS PER THE IFU. THE FACILITY HAD BEEN TREATING OTHER PTS WITH THIS UNIT DURING THE SAME TIME PERIOD, WITHOUT INCIDENT OR COMPLAINTS OF EXCESSIVE HEAT. THE PT INVOLVED IN THIS INCIDENT HAD RECEIVED 8 PRIOR TREATMENTS WITH THIS UNIT WITHOUT INCIDENT. ADDITIONALLY, THE TREATING THERAPIST BELIEVES THE PT USED A TOPICAL HEATING OINTMENT PRIOR TO TREATMENT, WHICH IS CONTRARY TO RECOMMENDATIONS AS PER THE IFU. THE UNIT INVOLVED IN THIS INCIDENT HAS NOT BEEN RETURNED FOR EVALUATION. BASED UPON HISTORICAL INFO, IT IS LIKELY THAT THE UNIT IS PERFORMING WITHIN SPECIFICATION, HOWEVER, NO CONCLUSION CAN BE DRAWN UNLESS THE UNIT IS RETURNED FOR EVALUATION. 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.

Description of Event or Problem

TREATING THERAPIST REPORTED THAT PT DEVELOPED A BURN ON THE CALF FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL MODEL.