BEUDAMED
    FDA Adverse Event Other Summary report: N

    JON + ALERT

    MDR report key: 3677423 · Received March 10, 2014

    Report

    Report Number
    MW5034908
    Event Type
    Other
    Date Received
    March 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC SYSTEMS, INC.
    Product Code
    NXQ
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I'M LOOKING TO FIND OUT IF AN ACTIVELY LOCKED/ UNLOCKED, REMAINDERED PULL DISPENSING SYSTEM SHOULD BE FDA CONTROLLED. I HAVE CONCERNS THAT FLAWS IN THE DESIGN, IF IT WERE NOT APPROVED BY THE FDA, COULD RESULT IN PT HARM (NO PILLS, TOO MANY PILLS, ETC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142380 JON + ALERT JON + ALERT NXQ MEDTRONIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1