BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL ELECTRIC OHMEDA

    MDR report key: 1897347 · Received November 4, 2010

    Report

    Report Number
    MW5018112
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    OHMEDA DIV BOC HEALTHCARE INC
    Product Code
    LBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REDDENED AREA, POSSIBLE BURN, NOTED ON INFANT UNDER LIGHT FOR PHOTOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC OHMEDA PHOTOTHERAPY LIGHT UNIT LBI OHMEDA DIV BOC HEALTHCARE INC OHMEDA/6600-0287-90

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA