BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREPERITONEAL DISTENSION BALLOON SYSTEM

    MDR report key: 15966 · Received September 8, 1994

    Report

    Report Number
    MW1003285
    Event Type
    Injury
    Date Received
    September 8, 1994
    Date of Event
    August 5, 1994
    Report Date
    September 6, 1994
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC INGUINAL HERNIA REPAIR WITH 10 MM TROCAR AND INFLATABLE BALLOON. UPON INFLATION OF BALLOON AFTER INSERTION INTO TROCAR, THE BALLOON BURST. A PIECE OF THE BALLOON HAD TO BE REMOVED FROM THE PT BY THE SURGEON. A NEW TROCAR AND BALLOON WERE SUBSEQUENTLY TRIED AND THE SAME THING OCCURRED. THE ATTENDING NURSE STATES THAT THE LOCAL SALES REP WAS PRESENT DURING THE PROCEDURES AND HE STATED THAT THIS BALLOON RUPTURE IS NOT INFREQUENT WITH THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPERITONEAL DISTENSION BALLOON SYSTEM GBA ORIGIN MEDSYSTEMS, INC. PDB 1000 1230052694

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention