BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7154354 · Received December 28, 2017

    Report

    Report Number
    MW5074279
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    December 4, 2017
    Report Date
    December 27, 2017
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED INJECTION OF SYNVISC ONE ON (B)(6) 2017 INTO RIGHT KNEE. ON (B)(6) 2017 PATIENT REPORTED SWELLING, INCREASED KNEE PAIN, AND INFLAMMATION OF RIGHT KNEE. DOSE OR AMOUNT: 6 ML MILLILITRE(S). FREQUENCY: OTHER - ONCE. ROUTE: INTRA-ARTICULAR. THERAPY START DATE: (B)(6) 2017. THERAPY END DATE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: ARTHRITIS OF RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929874 SYNVISC ONE SYNVISC ONE MOZ GENZYME CORPORATION 7RSL025

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR