BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN-3 INJ 16.8/2ML

    MDR report key: 9349222 · Received November 19, 2019

    Report

    Report Number
    MW5091200
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 15, 2019
    Manufacturer
    IBSA FARMACEUTICI ITALIA SRL
    Product Code
    MOZ
    UDI-DI
    89130311101
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OFF LABEL USE PT USING GELSYN FOR OSTEOARTHRITIS OF THE RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137211 GELSYN-3 INJ 16.8/2ML ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA FARMACEUTICI ITALIA SRL 89130311101

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR