BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNITROPE PEN

    MDR report key: 8817597 · Received July 22, 2019

    Report

    Report Number
    MW5088290
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 15, 2019
    Manufacturer
    SANDOZ INC.
    Product Code
    KZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S FATHER CALLED IN AND EXPRESSED CONCERN THAT THE OMNITROPE PEN FOR USE WITH OMNITROPE 10MG CARTRIDGES IS BROKEN. HE STATES HIS SON HAS BEEN TELLING HIM HE DOES NOT GET THE FULL DOSE WHEN INJECTING; HOWEVER FATHER HAS BEEN AWAY ON BUSINESS AND IS UNSURE OF THE SPECIFICS AS TO WHAT IS HAPPENING AND HOW SON KNOWS HE IS NOT GETTING FULL DOSE. I SCHEDULED A VIDEO CONSULTATION WITH A RPH TO REVIEW ADMINISTRATION TECHNIQUE AND PROVIDE PHONE INFO TO LOOK INTO NEW PEN DEVICE AS THEIRS IS GREATER THAN 1 YEAR OLD PER FATHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603920 OMNITROPE PEN INTRODUCER, SYRINGE NEEDLE KZH SANDOZ INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR