ANODYNE THERAPY

Additional Manufacturer Narrative

TREATING THERAPIST REPORTED THAT THE PT DEVELOPED A THIRD DEGREE BURN FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL MODEL. ANODYNE HAS NOT BEEN ABLE TO CONFIRM THE ACCURACY OF THIS INJURY ASSESSMENT, AND IN FACT WAS PROVIDED INFO THAT IS CONSISTENT WITH A 2ND DEGREEN BURN, IE. THE PT WAS TREATED BY THEIR PHYSICIAN WITH SILVADENE, AND THE PT INJURY HAD DEVELOPED A SCAB (HEALING) WITHIN EIGHT DAYS. TO DATE, NO TREATMENT NOTES HAVE BEEN PROVIDED AS REQUESTED. THE PT INVOLVED IN THIS EVENT HAD RECEIVED 8 PRIOR ANODYNE TREATMENTS WITHOUT INCIDENT, AND THE THERAPIST REPORTS TREATING TIME AND INTENSITY THAT IS CONSISTENT WITH THE GUIDELINES PROVIDED IN THE IFU. THE ANODYNE UNIT HAD CONCURRENTLY BEEN USED ON OTHER PTS WITHOUT INCIDENT. THE UNIT REPORTEDLY INVOLVED IN THIS EVENT HAS BEEN RETURNED TO ANODYNE FOR EVAL. THE UNIT WAS FOUND TO HAVE A DEFECTIVE HOUSING ON THE SPLITTER, WHICH WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. MOREOVER, THE UNIT OPERATES WITHIN THE TEMPERATURE GUIDELINES, INDICATING THE UNIT WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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 THESE EVENTS.

Description of Event or Problem

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