BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACEMAKER II

    MDR report key: 341265 · Received July 6, 2001

    Report

    Report Number
    MW1022345
    Event Type
    Injury
    Date Received
    July 6, 2001
    Date of Event
    April 25, 2001
    Report Date
    June 20, 2001
    Manufacturer
    GENERAL SURGICAL INNOVATIONS, INC.
    Product Code
    GDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RUPTURE OR TEAR OF URINARY BLADDER AS RESULT OF USING A PREPERITONEAL DISSECTION BALLOON TO PERFORM A LAPAROSCOPIC INGUINAL HERNIORRHAPHY. REQUIRED SURGICAL REPAIR OF BLADDER INJURY AND HOSPITALIZATION FOR CONTROL OF LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30707 SPACEMAKER II SURGICAL BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS, INC. VSM 1000-01 REF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R