BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANODYNE THERAPY

    MDR report key: 1580004 · Received January 9, 2010

    Report

    Report Number
    1055581-2009-00004
    Event Type
    Injury
    Date Received
    January 9, 2010
    Date of Event
    November 13, 2009
    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

    HOSPITAL NOTIFIED COMPANY THAT THE ENERGY BARS FLUCTUATE ON THEIR SYSTEM. THIS SYSTEM WAS RETURNED FOR EVALUATION, AND THE POTENTIOMETER SWITCH WAS FOUND TO BE DEFECTIVE, AND REPLACED. COMPANY DID NOT SUBMIT AN MDR AT THAT TIME AS THIS DEFECT WOULD NOT CAUSE THE SYSTEM TO OPERATE AT UNSAFE TEMPERATURES. ON DECEMBER 14, COMPANY WAS NOTIFIED THAT THE HOSPITAL HAD ALSO EXPERIENCED AN ADVERSE EVENT. DETAILS OF THIS ADVERSE EVENT ARE NOT KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN SUFFICIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    HOSPITAL NOTIFIED COMPANY THAT THE ENERGY BARS FLUCTUATE ON THEIR SYSTEM. COMPANY WAS SUBSEQUENTLY NOTIFIED THAT THE HOSPITAL ALSO EXPERIENCED AN ADVERSE EVENT.

    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 82 YR Required Intervention