BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL BALLOON DISSECTOR

    MDR report key: 19686 · Received December 22, 1994

    Report

    Report Number
    19686
    Event Type
    Death
    Date Received
    December 22, 1994
    Date of Event
    December 14, 1994
    Report Date
    December 22, 1994
    Manufacturer
    GENERAL SURGICAL INNOVATIONS, INC.
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIFTY-FIVE-YR-OLD BM UNDERWENT INCISIONAL VENTRAL HERNIA REPAIR AND LAPAROSCOPIC INGUINAL HERNIA REPAIR. RESPIRATORY ARREST WITH SUDDEN DEATH 2 DAYS POST OP. AUTOPSY REVEALED PERFORATED SMALL BOWEL WITH SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL BALLOON DISSECTOR SPACEMAKER-SURGICAL BALLOON DISSECTOR GDI GENERAL SURGICAL INNOVATIONS, INC. SBD-600

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| O