BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPODERMIC NEEDLE

    MDR report key: 7083991 · Received December 4, 2017

    Report

    Report Number
    MW5073742
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    NOVO NORDISK, INC.
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S MOTHER REPORTED PEN NEEDLES CHANGED TO AUTOCOVER FROM REGULAR 2 ORDERS AGO. RX FOR 30G 8MM NOVOFINE. REFILLS/DS INCORRECT ON ORIGINAL AND APPEARS SOMEONE ADDED NEW RX TO CORRECT THE ISSUE AND THEN CHANGED TO AUTOCOVER. MOM HAVING ISSUE WITH USE AND WANTS CORRECT PEN NEEDLES. CORRECTING ISSUE AND SENDING ASAP. NO MISSED DOSES REPORTED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859282 HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI NOVO NORDISK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR