BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY

    MDR report key: 1509107 · Received October 6, 2009

    Report

    Report Number
    1055581-2009-00003
    Event Type
    Malfunction
    Date Received
    October 6, 2009
    Date of Event
    August 21, 2009
    Report Date
    October 6, 2009
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND AN IC TIMER FAILURE WAS DETECTED. NO ADVERSE EVENT WAS REPORTED, HOWEVER, THIS TYPE OF MALFUNCTION COULD POTENTIALLY CAUSE AN ADVERSE 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 EVENTS OF THIS TYPE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE THERAPY PADS OF THEIR ANODYNE SYSTEM WERE GETTING TOO WARM. WE REQUESTED THEY RETURN THE SYSTEM FOR EVALUATION, AND THE 555 TIMER WAS FOUND TO BE DEFECTIVE. THERE WAS NO ADVERSE EVENT REPORTED.

    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