BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 4243861 · Received November 11, 2014

    Report

    Report Number
    2647580-2014-00978
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE BALLOON IS BREAKING AND CANNOT BE FILLED GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726384 SPACEMAKER BLUNT TIP TROCAR 12MM SPACE MAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMST12BT P3K0066X

    Patients

    Seq Age Sex Outcome Treatment
    1