BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC-ONE HYLAN G-F 20

    MDR report key: 10809828 · Received November 6, 2020

    Report

    Report Number
    MW5097695
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    June 29, 2016
    Report Date
    September 1, 2016
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED SEVERE PAIN (LEVEL 8/10) UPON INJECTION OF THE PRODUCT IN BOTH KNEES. THE FOLLOWING DAY, EXPERIENCED JOINT PAINS THROUGHOUT THE BODY WHICH LASTED 1 WEEK. SINCE THE EVENT, HAS HAD SWELLING IN BOTH KNEES AND CONSTANT PAIN SHE RATES AT A LEVEL OF 4/10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262890 SYNVISC-ONE HYLAN G-F 20 ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION 58468-0090-03 6RSL014

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other