BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE PEN NED 4MM 100'S - 32G5/32

    MDR report key: 8965887 · Received September 4, 2019

    Report

    Report Number
    MW5089587
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 25, 2019
    Report Date
    August 25, 2019
    Manufacturer
    ULTI MED, INC.
    Product Code
    FMI
    UDI-DI
    08222095435
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ABOUT 6 OUT OF EVERY 100 PEN NEEDLES ARE BENT FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757028 ULTICARE PEN NED 4MM 100'S - 32G5/32 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI ULTI MED, INC. 9190225 08222095435

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR