BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE - HYLAN G-F20

    MDR report key: 2033269 · Received March 25, 2011

    Report

    Report Number
    MW5019960
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    July 1, 2010
    Report Date
    March 16, 2011
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRIMARY PHYSICIAN REFERS TO ORTHO-SURGEON FOR APPT FOR PAIN IN KNEES, SURGEON TAKES X-RAYS OF BOTH KNEES, DID NOT DISCUSS WITH ME, HIS INTENT TO TREAT EXCEPT, ASKED IF I WAS ALLERGIC TO EGGS (NO). INJECTS SYNVISC ONE (1) IN EACH KNEE FROM BOTTOM OF KNEE. IMMEDIATELY KNEES TURNED STIFF, LIKE CEMENT. EXTREMELY PAINFUL - COULD NOT MOVE LEGS FOR WALKING. KNEES STIFF AND PAINFUL UP TO THIS DATE, 8 MONTHS, 20% BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE - HYLAN G-F20 INJECTION MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| S