BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONNER MANIPUJECTOR

    MDR report key: 2091761 · Received May 5, 2011

    Report

    Report Number
    2091761
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    COOPER SURGICAL
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SMALL DEBRIS NOTED INSIDE STERILE PACKAGING PRIOR TO OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRONNER MANIPUJECTOR UTERINE MANIPULATOR-INJECTOR LKF COOPER SURGICAL 6003 104942

    Patients

    Seq Age Sex Outcome Treatment
    1 *