BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGIN BALLOON (DISPOSABLE)

    MDR report key: 142376 · Received January 8, 1998

    Report

    Report Number
    MW1012766
    Event Type
    Injury
    Date Received
    January 8, 1998
    Date of Event
    December 19, 1997
    Report Date
    December 30, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC HERNIA REPAIR, ORIGIN BALLOON RUPTURED WHILE IN PT. RETRIEVED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN BALLOON (DISPOSABLE) * GCJ ORIGIN MEDSYSTEMS, INC. * 0209975

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention