BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY

    MDR report key: 1731328 · Received June 18, 2010

    Report

    Report Number
    1055581-2010-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 18, 2010
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND A VOLTAGE REGULATOR 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 BAR GRAPH DISPLAY DID NOT GO TO THE MAXIMUM SETTING. WE REQUESTED THAT THE UNIT BE RETURNED FOR EVALUATION, AND A REGULATOR 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 480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1