BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 908724 · Received September 7, 2007

    Report

    Report Number
    1055581-2007-00015
    Event Type
    Injury
    Date Received
    September 7, 2007
    Date of Event
    June 13, 2007
    Report Date
    September 7, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS REPORTED TO HAVE DEVELOPED A BURN, APPROX 2 1/2" X 1 1/2" ON HIS MEDIAL ANKLE FOLLOWING TREATMENT WITH THE ANODYNE PROFESSIONAL SYSTEM. THE HEALTH CARE PROFESSIONAL ADMINISTERED TREATMENT FOR 30 MINUTES AT AN ENERGY SETTING OF 8. THIS IS WITHIN THE GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INFO AND INSTRUCTIONS PROVIDED TO THE USER BY ANODYNE. THE UNIT INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION, AND DUTY CYCLE FAILURE WAS DETECTED. 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 EVENTS OF THIS NATURE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    PT IS REPORTED TO HAVE DEVELOPED A BURN ON HIS MEDIAL ANKLE, FOLLOWING TREATMENT WITH THE ANODYNE THERAPY PROFESSIONAL SYSTEM. PT WAS BEING TREATED BY A HEALTH CARE PROFESSIONAL FOR DIABETIC PERIPHERAL NEUROPATHY. PT WAS TREATED BY HIS DOCTOR WITH AN ANTIBIOTIC OINTMENT, AND HIS WOUND IS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention