BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLATOPA

    MDR report key: 9225384 · Received October 22, 2019

    Report

    Report Number
    MW5090588
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    October 19, 2019
    Report Date
    October 22, 2019
    Manufacturer
    SANDOZ GMBH / SANDOZ INC.
    Product Code
    KZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT A PROBLEM WITH HER GLATOPA SYRINGE. PT STATED IN 2017, SHE REPORTED TO THE MFR A PROBLEM WHERE, A COUPLE TIMES, HER NEEDLE BECAME STUCK IN HER SKIN, AND CAUSED A PAINFUL REACTION. PT SAID THIS ISSUE HAS HAPPENED AGAIN ON (B)(6) 2019. PT SAID THERE WAS A BARB AT THE END OF THE NEEDLE THAT BECAME STUCK. PT SAID THE NEEDLE IS VERY HARD TO REMOVE, IT'S PAINFUL AND LEAVES A WELT. PT SAID SHE WANTED TO DO HER PART AND REPORT THE PROBLEM TO HAVE ON RECORD WITH FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011871 GLATOPA INTRODUCER, SYRINGE NEEDLE KZH SANDOZ GMBH / SANDOZ INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other