BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANODYNE THERAPY

    MDR report key: 2464061 · Received February 14, 2012

    Report

    Report Number
    1055581-2012-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION AND A FET DRIVER 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 HIS UNIT WAS GETTING TOO WARM. WE REQUESTED THAT THE CUSTOMER RETURN THE UNIT TO US FOR EVALUATION. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANODYNE THERAPY POWERED HEATING PAD IRT ANODYNE THERAPY, LLC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1