BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER SEPS BALLOON DISSECTOR

    MDR report key: 203743 · Received December 21, 1998

    Report

    Report Number
    2951239-1998-00005
    Event Type
    Malfunction
    Date Received
    December 21, 1998
    Date of Event
    December 1, 1998
    Report Date
    December 1, 1998
    Manufacturer
    GENERAL SURGICAL INNOVATIONS
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A COMPONENT OF BALLOON DISSECTOR REMAINED IN BODY. FOLLOWING, REMOVAL OF DEVICE, PHYSICIAN NOTICED AND REMOVED COMPONENT IMMEDIATELY. THERE WAS NO PT INJURY OR ADVERSE REACTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER SEPS BALLOON DISSECTOR BALLOON DISSECTOR GDT GENERAL SURGICAL INNOVATIONS VBD-240T 807021

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death