BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOVISC INJ

    MDR report key: 9632369 · Received January 24, 2020

    Report

    Report Number
    MW5092516
    Event Type
    Injury
    Date Received
    January 24, 2020
    Date of Event
    January 18, 2020
    Report Date
    January 18, 2020
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OFF LABEL-USE OF MONOVISC FOR USE IN THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92983 MONOVISC INJ ACID, HYALURONIC, INTRAARTICULAR MOZ ANIKA THERAPEUTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR