ANODYNE THERAPY

Description of Event or Problem

PATIENT IS REPORTED TO HAVE DEVELOPED A BURN ON HER CALF FOLLOWING TREATMENT WITH THE ANODYNE SYSTEM WHICH WAS ADMINISTERED BY A HEALTH CARE PROFESSIONAL. THE BURN MEASURED APPROXIMATELY 2 INCHES IN DIAMETER AND WAS LOCATED ON HER RIGHT CALF. THE PATIENT HAS RECEIVED MEDICAL TREATMENT AND IS HEALING.

Additional Manufacturer Narrative

FACILITY REPORTED THEY TREATED THIS PATIENT FOR PERIPHERAL NEUROPATHY FOR 30 MINUTES AT AN ENERGY SETTING OF 8-10 WHICH EXCEEDS THE TREATMENT GUIDELINES PROVIDED IN OUR IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE TREATING THERAPIST ALSO INDICATED PADS TOO TIGHT. THIS PATIENT HAD RECEIVED 8 PRIOR TREATMENTS WITH THIS UNIT WITHOUT INCIDENT. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION AND NO DEFECTS IDENTIFIED. SINCE 09/20/2007, COMPANY AND TREATING THERAPIST HAVE MADE NUMEROUS ATTEMPTS TO OBTAIN INFORMATION NECESSARY TO DETERMINE IF THIS IS A REPORTABLE EVENT. REQUIRED INFORMATION BECAME AVAILABLE 10/23. THE NUMBER OF INCIDENTS OF THIS TYPE REMAIN WELL WITHIN THE EXPECTED RATE FOR THIS PRODUCT BASED UPON THE NUMBER OF INCIDENTS REPORTED AND THE NUMBER OF UNITS IN DISTRIBUTION. COMPANY WILL CONTINUE TO MONITOR AND TREND EVENTS OF THIS NATURE.