BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTIK

    MDR report key: 6507170 · Received April 20, 2017

    Report

    Report Number
    6507170
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 4, 2017
    Manufacturer
    OWEN MUMFORD USA, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LANCETS ON THE UNIT CONTINUE TO MALFUNCTION. ONCE THE SAFETY IS TWISTED OFF THE LANCET, THE DEVICE FALLS APART EXPOSING A NEEDLE. OF NOTE, THE SAME LOT NUMBER CONTINUES TO BE AN ISSUE. THE LOT IN QUESTION BEING PULLED FROM SHELVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290394 UNISTIK LANCET, BLOOD FMK OWEN MUMFORD USA, INC. 28 G, 1.8 MM 160821

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR