BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEILING MOUNTED RADIATION SHIELD

    MDR report key: 136108 · Received December 1, 1997

    Report

    Report Number
    2126677-1997-00038
    Event Type
    Injury
    Date Received
    December 1, 1997
    Date of Event
    October 9, 1997
    Report Date
    October 10, 1997
    Manufacturer
    UNITED SHIELDING
    Product Code
    IWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE THAT THE RAD SHIELD FELL AND STRUCK THE PT. APPARENTLY, THIS CAUSED TRAUMA TO THE LIVER OF THE PT AND DAMAGED THE TABLE. THE EQUIPMENT HAS BEEN TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEILING MOUNTED RADIATION SHIELD DIAGNOSTIC X-RAY IWQ UNITED SHIELDING UST-400R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R