BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 3810336 · Received April 10, 2014

    Report

    Report Number
    2647580-2014-00265
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 21, 2013
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BALLOON POPPED. NO OPERATING ROOM TIME EXTENSION. RETRIEVED ALL THE PIECES OF THE BALLOON. PIECES OF BALLOON WERE NOT NOTED TO HAVE FALLEN IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216268 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2K0598X

    Patients

    Seq Age Sex Outcome Treatment
    1