BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE INJ 8MG/ML

    MDR report key: 6198167 · Received December 20, 2016

    Report

    Report Number
    MW5066847
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    GENZYME
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT AN ADVERSE REACTION FROM HER SYNVISC-ONE INJECTION GIVEN (B)(6), AT MDO. THE RIGHT KNEE AND SEVERE SWELLING, SKIN TIGHTNESS, AND PAIN RADIATING UPPER THIGH. FEVER AND NIGHT SWEATING (B)(6). MDO WAS AWARE AND ADVISED PT TO GO IN TO DRAIN THE SITE, BUT SHE DECLINED AND RECEIVED AND TOOK 2ND PREDNISONE WHICH HELPED TREMENDOUSLY. SHE HAD AN INITIAL INJECTION IN (B)(6) 2016 WITHOUT ANY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840360 SYNVISC ONE INJ 8MG/ML HYALURONIC ACID MOZ GENZYME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR