BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY

    MDR report key: 862945 · Received June 7, 2007

    Report

    Report Number
    1055581-2007-00009
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    December 20, 2006
    Report Date
    June 7, 2007
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND DUTY CYCLE FAILURE WAS DETECTED. NO ADVERSE EVENT WAS REPORTED, HOWEVER, THIS TYPE OF MALFUNCTION COULD POTENTIALLY CAUSE AN ADVERSE EVENT. THE DESIGN AND FUNCTIONALITY OF ANODYNE'S DEVICES DOES NOT SUGGEST THAT THERE IS AN ANTICIPATED OR "USUAL" FREQUENCY AND SEVERITY OF OCCURRENCE FOR THE INCIDENT REPORTED IN OUR MDR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE THERAPY PADS ON THEIR PROFESSIONAL UNIT WERE GETTING TOO WARM. WE REQUESTED THAT THEY RETURN THE UNIT FOR EVALUATION, AND THEIR DUTY CYCLE 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 YR