BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE

    MDR report key: 3924904 · Received July 7, 2014

    Report

    Report Number
    3924904
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COOK, INC.
    Product Code
    LQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE STONE BASKET WOULD NOT OPEN TO RETRIEVE THE STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393139 NGAGE DISLODGER, STONE, BASKET, URETERAL, METAL LQR COOK, INC. NGE-017115-MB U2475113

    Patients

    Seq Age Sex Outcome Treatment
    1 *