BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7145509 · Received December 22, 2017

    Report

    Report Number
    MW5074210
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    June 1, 2017
    Report Date
    December 21, 2017
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED ABOUT LUMO ON RIGHT KNEE AFTER THE FIRST INJECTION APPROX. 6 MONTHS AGO. THE NON-CANCEROUS TUMOR IS BIGGER THAN HER KNEE CAP, HAS TO SEE A PLASTIC SURGEON TO GET IT REMOVED NEXT MONTH. SAYS SHE ADVISED MDO OF THIS AND HE STILL PRESCRIBED IT. DOSE OR AMOUNT: 6 ML MILLILITER(S). FREQUENCY: OTHER; ONCE IN 6 MONTHS. ROUTE: INTRA-ARTICULAR. DIAGNOSIS OR REASON FOR USE: UNILATERAL PRIMARY OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920633 SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION 5RSE058

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other