BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER EXTRA VIEW BALLOON - OVAL

    MDR report key: 3924944 · Received June 24, 2014

    Report

    Report Number
    2647580-2014-00473
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K954175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: BOTH BALLOONS RUPTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367209 SPACEMAKER EXTRA VIEW BALLOON - OVAL SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC P4A0377X

    Patients

    Seq Age Sex Outcome Treatment
    1