BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTIK

    MDR report key: 6499706 · Received April 18, 2017

    Report

    Report Number
    6499706
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 30, 2017
    Report Date
    March 31, 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 THE CERTIFIED NURSING ASSISTANT (CNA) TWISTS OFF THE SAFETY CAP FOR THE UNISTIK TOUCH LANCET, THE ENTIRE LANCET FALLS APART. A CNA HAS SUSTAINED A CLEAN NEEDLE STICK AS A RESULT. I HAVE BEEN INFORMED OF SIMILAR EVENTS OCCURRING WITH THIS DEVICE. CURRENTLY INVESTIGATING TO DETERMINE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282733 UNISTIK LANCET, BLOOD FMK OWEN MUMFORD USA, INC. 28G, 1.8 MM 160821

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other