BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTIK

    MDR report key: 6493189 · Received April 14, 2017

    Report

    Report Number
    6493189
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 29, 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

    WHEN I TWIST OFF THE LANCET CAP, THE BACK OF THE LANCET POPS OFF AND THE NEEDLE IS EXPOSED. THIS HAD HAPPENED WITH SEVERAL LANCETS. THIS SITUATION HAPPENED BEFORE CHECKING THE PATIENT'S BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274458 UNISTIK LANCET, BLOOD FMK OWEN MUMFORD USA, INC. 160821

    Patients

    Seq Age Sex Outcome Treatment
    1