BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 3040330 · Received October 2, 2007

    Report

    Report Number
    1055581-2007-00017
    Event Type
    Injury
    Date Received
    October 2, 2007
    Date of Event
    September 1, 2007
    Report Date
    October 1, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAS BEEN USING HER ANODYNE UNIT FOR 16 MONTHS TO TREAT PERIPHERAL NEUROPATHY WITH NO PREVIOUS INCIDENT. ON (B)(6) 2007, SHE REPORTS SHE DEVELOPED BLISTERS ON HER INNER LEFT CALF FOLLOWING TREATMENT APPLICATION FOR 30 MINUTES. THIS TREATMENT TIME IS WITHIN THE GUIDELINES PROVIDED IN THE IMPORTANT SAFETY INFORMATION AND INSTRUCTION MANUAL. THE UNIT INVOLVED IN THIS INCIDENT HAS BEEN RETURNED FOR EVALUATION, AND FOUND TO OPERATING WITHIN SPECIFICATIONS. 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

    PATIENT IS REPORTED TO HAVE DEVELOPED SMALL BLISTERS ON THE LEFT CALF FOLLOWING TREATMENT WITH THE ANODYNE HOME UNIT. PATIENT APPLIED POLYSPORIN, WHICH WAS PRESCRIBED BY HER PHYSICIAN, AND HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY INFRARED LAMP ILY ANODYNE THERAPY, LLC 120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention