BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN

    MDR report key: 134873 · Received July 1, 1997

    Report

    Report Number
    134873
    Event Type
    Malfunction
    Date Received
    July 1, 1997
    Date of Event
    January 17, 1997
    Report Date
    January 29, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRUCTURAL BALLOON USED FOR LAPAROSCOPIC PREPERITONEAL HERNIA INFLATED WITH 30CC OF AIR PER MFR'S INSTRUCTION, RUPTURED CAUSING MULTIPLE BALLOON PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN SURGICAL TROCAR AND SYRINGE (BLUNT TIP) GCJ ORIGIN MEDSYSTEMS, INC. 00997 0902961

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other