BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 2990256 · Received February 7, 2013

    Report

    Report Number
    2647580-2013-00067
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    November 22, 2012
    Report Date
    January 16, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    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 THE BALLOON WAS INFLATED, THE VALVE BROKE. NO ILL EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52773 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P2H0801X

    Patients

    Seq Age Sex Outcome Treatment
    1