BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 3901881 · Received June 23, 2014

    Report

    Report Number
    MW5036887
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 17, 2014
    Manufacturer
    GENZYME
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INJECTION OF SYNVISCONE INTO RIGHT KNEE UNDER STERILE CONDITIONS. A (B)(6) MAN WITH PRIOR HISTORY OF GOUT, 2 PREVIOUS ARTHROSCOPIC RIGHT KNEE PROCEDURES, DSD RIGHT KNEE BY MRI, TRAY RIGHT KNEE WAS INJECTED ON (B)(6) 2014 WITH SYNVISC ONE UNDER STERILE CONDITIONS. TWO DAYS LATER PAIN AND SWELLING RIGHT KNEE. KNEE ASPIRATED (B)(6) 2014. A 40ML CLOUDY FLUID REMOVED. REASPIRATED (B)(6) 2014 - 50 ML CLOUDY FLUID REMOVED RESULTS BELOW ADMITTED (B)(6) 2014. ARTHROSCOPIC DRAINAGE, DEBRIDEMENT (B)(6) 2004 TO HOSPITAL. DOSE OF AMOUNT: 6ML, FREQUENCY X 1, ROUTE: INTRAARTICULAR KNEE DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS RIGHT KNEE GOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366786 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME P1303

    Patients

    Seq Age Sex Outcome Treatment
    1 02/16/1 Hospitalization| O