BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC

    MDR report key: 10829304 · Received November 10, 2020

    Report

    Report Number
    MW5097800
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Report Date
    June 17, 2005
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN I INJECTED SYNVISC INTO PATIENT'S JOINT, A PORTION OF MEDICATION LEAKED OUT FROM THE AIDE OF THE PRE-FILLED SYRINGE. THIS HAPPENS ABOUT ONE IN 20 INJECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279719 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION Q0519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other