BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DROPLET PEN

    MDR report key: 8363119 · Received February 21, 2019

    Report

    Report Number
    MW5084246
    Event Type
    Injury
    Date Received
    February 21, 2019
    Report Date
    February 13, 2019
    Manufacturer
    HTL-STREFA, INC
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS DROPLET BRAND PAN NEEDLES ARE DIFFICULT TO USE TO INJECT INSULIN. HE IS NOT SURE IF HE IS GETTING THE RIGHT DOSE SINCE THEY ARE HARD TO PUSH AND LEAK. THESE POORLY MADE PEN NEEDLES ARE PREVENTING THIS PATIENT FROM APPROPRIATELY DOSING HIS INSULIN. SYMPTOMS: INAPPROPRIATE INSULIN ADMINISTRATION, POTENTIAL UNDER-DOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153890 DROPLET PEN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HTL-STREFA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other