BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSILLUMINATOR

    MDR report key: 856654 · Received May 23, 2007

    Report

    Report Number
    MW5001964
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    May 23, 2007
    Report Date
    May 23, 2007
    Manufacturer
    CHIU TECHNICAL CORPORATION
    Product Code
    LEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSILLUMINATOR WAS BEING USED TO ASSIST IN STARTING AN INTRAVENOUS LINE ON A NEWBORN INFANT. MULTIPLE BURNS WERE DISCOVERED FOLLOWING USE OF EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSILLUMINATOR LEK CHIU TECHNICAL CORPORATION BFO-150

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other