ANODYNE THERAPY

Description of Event or Problem

A DEFECTIVE HOUSING WAS FOUND IN THE CORD OF AN ANODYNE PROFESSIONAL UNIT THAT WAS RETURNED FOR EVAL. HEALTH CARE PROFESSIONAL REPORTED A PT HAD DEVELOPED A SMALL BLISTER (1 CM X 1 1/2 CM) ON HIS CALF FOLLOWING TREATMENT WITH THE UNIT. PT DID NOT REQUIRE MEDICAL INTERVENTION.

Additional Manufacturer Narrative

THERAPIST REPORTED TREATING THIS PT FOR 30 MINUTES AT AN ENERGY SETTING OF 8 WHICH IS WITHIN THE RECOMMENDED TREATMENT GUIDELINES. PT DID NOT REQUIRE MEDICAL INTERVENTION. THE UNIT INVOLVED IN THIS INCIDENT WAS RETURNED FOR EVAL. A DEFECTIVE HOUSING WAS IDENTIFIED IN THE CORDS ON THE UNIT, WHICH CAUSED ONE THERAPY PAD TO REACH A TEMPERATURE THAT COULD CAUSE THIS INCIDENT. 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 NATURE.