BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML

    MDR report key: 8674747 · Received June 5, 2019

    Report

    Report Number
    MW5087150
    Event Type
    Injury
    Date Received
    June 5, 2019
    Date of Event
    May 30, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. C/O FERRING PHARMACEUTICALS INC.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A REP FROM THE DR'S OFFICE CALLED IN TO PRESCRIBE EUFLEXXA TO BE INJECTED INTO THE SHOULDER AND CONFIRMED OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462890 EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ACID, HYALURONIC, INTRAARTICULAR MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. C/O FERRING PHARMACEUTICALS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR