BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE PEN NED 6MM 100S/31G, 1/4

    MDR report key: 19208566 · Received April 26, 2024

    Report

    Report Number
    MW5154404
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 19, 2024
    Manufacturer
    ULTI MED, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE KEEPS BENDING AND NOT ADMINISTERING MEDICATION, AND NEEDLE DOES NOT ATTACH TO PEN WELL EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172751 ULTICARE PEN NED 6MM 100S/31G, 1/4 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ULTI MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male