BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURTON FOR OHMEDA MEDICAL

    MDR report key: 555881 · Received August 21, 2004

    Report

    Report Number
    MW1033415
    Event Type
    Injury
    Date Received
    August 21, 2004
    Date of Event
    April 19, 2004
    Report Date
    August 21, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHOTOTHERAPY LIGHT IN USE FOR APPROX 4-5 HRS. NOTED BURN ON ABDOMEN. LIGHT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURTON FOR OHMEDA MEDICAL INFANT WARMING SYSTEM AND PHOTOTHERAPY LIGHT II FMT OHMEDA MEDICAL 6600-0288-901 0600

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention