BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 3133923 · Received May 1, 2013

    Report

    Report Number
    2647580-2013-00237
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC P
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT WHEN INFLATED, THE BALLOON PIERCED. NO PIECES FELL INTO THE PT'S CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191070 SPACEMAKER BLUNT TIP TROCAR 12MM SPACEMAKER BALLOONS GCJ COVIDIEN, FORMERLY USSC P P2J0304X

    Patients

    Seq Age Sex Outcome Treatment
    1