BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXPRO

    MDR report key: 8662487 · Received May 31, 2019

    Report

    Report Number
    MW5087088
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 22, 2019
    Report Date
    May 22, 2019
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    KZH
    UDI-DI
    00169770821
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DUE TO A DISPENSING ERROR / OMISSION PT RECEIVED THE INCORRECT QUANTITY OF PEN NEEDLES FOR ADMINISTRATION, AND MAY HAVE LEAD TO A 10 DAY GAP IN THERAPY. PRESCRIBER INTENDED PT TO RECEIVE A TOTAL OF 100 DAYS WORTH OF MEDICATION AND NEEDLES FOR ADMINISTRATION A TOTAL OF 100 DAYS OF MEDICATION WAS SENT AND AN INSUFFICIENT AMOUNT OF NEEDLES WERE SENT. ERROR WAS CORRECTED AND REMAINING AMOUNT WILL BE DISPENSED TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452134 FLEXPRO INTRODUCER, SYRINGE NEEDLE KZH NOVO NORDISK INC. 00169770821

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR