BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE AUTOCOVER 30G DISPOSABLE SAFETY NEEDLE

    MDR report key: 17550829 · Received August 14, 2023

    Report

    Report Number
    MW5144562
    Event Type
    Injury
    Date Received
    August 14, 2023
    Date of Event
    April 18, 2023
    Report Date
    August 9, 2023
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6), MY MEDICARE PRESCRIPTION PROVIDER, CHANGED MY INSULIN PEN TIPS TO A DIFFERENT BRAND THAT DID NOT INJECT THE FULL AMOUNT (OR POSSIBLY ANY) OF INSULIN CAUSING ME TO INCREASE THE AMOUNTS OF INSULIN I USED WHILE STILL NOT RECEIVING THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528467 NOVOFINE AUTOCOVER 30G DISPOSABLE SAFETY NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. ME61182-1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| L AMLODIPINE| ATORVASTATIN| CLOPIDOGREL| INSULIN ASPART| INSULIN GLARGINE| VITAMIN D| VITAMIN E