BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER STRUCTURAL BALLOON TROCAR

    MDR report key: 3810321 · Received April 10, 2014

    Report

    Report Number
    2647580-2014-00264
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    January 24, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    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 FAILED DURING THE PROCEDURE. CLARIFICATION ABOUT FAILED NOT PROVIDED BY CALLER. NO TISSUE DAMAGE. OPERATING ROOM TIME NOT EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216267 SPACEMAKER STRUCTURAL BALLOON TROCAR SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1