BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN

    MDR report key: 35738 · Received August 15, 1996

    Report

    Report Number
    35738
    Event Type
    Injury
    Date Received
    August 15, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 8, 1996
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON EXPLODED. PIECES IN PT'S ABDOMEN; REMOVAL NECESSARY; IT DID NOT STAY IN TACT WHEN PUNCTURED BECAUSE IT DID NOT DECOMPRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN PREPERITONEAL DISTENSION BALLOON SYSTEM GBA ORIGIN MEDSYSTEMS, INC. PDB1000 1207951

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention