BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 127634 · Received October 9, 1997

    Report

    Report Number
    MW1012324
    Event Type
    Injury
    Date Received
    October 9, 1997
    Date of Event
    October 9, 1997
    Report Date
    October 15, 1997
    Manufacturer
    UNITED SHIELD CORP.
    Product Code
    IWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE IN THE CARDIAC CATHERIZATION LAB; LEAD RADIATION SHIELD FELL FROM THE CEILING ONTO THE PTS CHEST AND ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * RADIATION SAFETY SHIELD IWQ UNITED SHIELD CORP. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization