BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNISTIK

    MDR report key: 18664574 · Received February 7, 2024

    Report

    Report Number
    8021764-2024-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 10, 2024
    Report Date
    February 7, 2024
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMK
    PMA / PMN Number
    K221126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OMI'S CUSTOMER REPORTED THAT THEIR CUSTOMER REPORTED LANCETS NOT PROPERLY RETRACTING ONCE FINGERSTICK COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180095 UNISTIK LANCETS FMK OWEN MUMFORD LIMITED AT 1015 076666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown