BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 1580003 · Received January 9, 2010

    Report

    Report Number
    1055581-2009-00005
    Event Type
    Injury
    Date Received
    January 9, 2010
    Report Date
    January 8, 2010
    Manufacturer
    ANODYNE THERAPY, LLC
    Product Code
    ILY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY HAS BEEN NOTIFIED THAT THE HOSPITAL HAS EXPERIENCED AN ADVERSE EVENT WHILE USING THIS ANODYNE SYSTEM. DETAILS OF THIS EVENT ARE UNKNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN SUFFICIENT INFORMATION IS AVAILABLE. UNIT HAS BEEN RETURNED FOR EVALUATION, AND WILL BE EVALUATED WHEN ALL INFORMATION OF THE ADVERSE EVENT ARE KNOWN.

    Description of Event or Problem · 1

    COMPANY HAS BEEN NOTIFIED THAT THE HOSPITAL HAS EXPERIENCED AN ADVERSE EVENT WHILE USING ONE OF ITS ANODYNE SYSTEMS.

    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 Required Intervention