BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER XL ENEMA BAG SYSTEM

    MDR report key: 19442 · Received February 6, 1995

    Report

    Report Number
    MW1005028
    Event Type
    Injury
    Date Received
    February 6, 1995
    Date of Event
    January 27, 1995
    Report Date
    February 1, 1995
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FGD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF ENEMA TUBE IN RECTUM PERFORATED RECTUM. UPON EXTRACTION OF THE ENEMA TIP, THE BALLOON WAS REINFLATED, DEMONSTRATING AN UNEVENLY INFLATED BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER XL ENEMA BAG SYSTEM FGD E-Z-EM, INC. 29248925

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization