BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 837228 · Received April 12, 2007

    Report

    Report Number
    837228
    Event Type
    Injury
    Date Received
    April 12, 2007
    Date of Event
    January 29, 2005
    Report Date
    April 12, 2007
    Manufacturer
    CHIU TECHNICAL CORP
    Product Code
    HJM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US

    Narratives

    Description of Event or Problem · 1

    NEWBORN RECENTLY TRANSFERRED TO NICU FROM THE BIRTH HOSPITAL, WAS FOUND TO HAVE BLISTERING ALONG THE SIDE OF THE RIGHT LEG AFTER THE DRAPES WERE REMOVED FOLLOWING PICC LINE PLACEMENT. A TRANSILLUMINATOR HAD BEEN USED TO FACILITATE VEIN LOCATION. THE DEVICE WAS TESTED BY OUR BIOMED DEPT AND IT APPEARED TO BE WORKING CORRECTLY BUT IT WAS NOTED THAT THE BOX PART GOT VERY HOT IF COVERED BY A BLANKET OR TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LIGHT SOURCE HJM CHIU TECHNICAL CORP BFO-150 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention