BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSYN-3

    MDR report key: 9321996 · Received November 13, 2019

    Report

    Report Number
    MW5091078
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    November 9, 2019
    Report Date
    November 9, 2019
    Manufacturer
    IBSA INSTITUT BIOCHIMIQUE SA
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GELSYN IS BEING USED OFF LABEL FOR AREA OF INJECTION INTO THE SHOULDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113629 GELSYN-3 ACID, HYALURONIC, INTRAARTICULAR MOZ IBSA INSTITUT BIOCHIMIQUE SA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR