BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 118831 · Received September 8, 1997

    Report

    Report Number
    118831
    Event Type
    Injury
    Date Received
    September 8, 1997
    Date of Event
    September 4, 1997
    Report Date
    September 4, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FGY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISTENTION BALLOON POPPED OR BURST IN PT'S ABDOMEN DURING INFLATION. FRAGMENTS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN 2-PREPERITONEAL DISTENTION BALLOON & INFLATION BULB FGY ORIGIN MEDSYSTEMS, INC. POB1000 0107971

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization VISUAL ONLY