BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGINS

    MDR report key: 18496 · Received September 15, 1994

    Report

    Report Number
    18496
    Event Type
    Injury
    Date Received
    September 15, 1994
    Date of Event
    September 7, 1994
    Report Date
    September 15, 1994
    Manufacturer
    ORIGINS MEDISYSTEMS, INC.
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR LAPOROSCOPI LEFT HERNIA REPAIR. PHYSICIAN INSERTED PREPERITIONEAL DISTENTION BALLOON IN INNCISION BELOW UMBILICUS, ATTEMPTED TO INFLATE BALLOON; BALLOON POPPED. ANOTHER BALLOON WAS INSERTED AND PHYSICIAN ATTEMPTED TO INFLATE; THE BALLOON POPPED. ON INSERTION OF THE LAPAROSCOPE, IT WAS DISCOVERED THAT THE BLADDER WAS PERFORATED. A UROLOGIST WAS IMMEDIATELY CONSULTED FOR REPAIR. THE COMPANY SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGINS PREPERITONEAL DISTENTION BALLOON SYSTEM EZL ORIGINS MEDISYSTEMS, INC. 123E061394 & 1230061594

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention