BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC 8 MG/CC

    MDR report key: 277180 · Received May 3, 2000

    Report

    Report Number
    MW1018852
    Event Type
    Other
    Date Received
    May 3, 2000
    Date of Event
    September 28, 1999
    Report Date
    May 3, 2000
    Manufacturer
    WYETH-LABORATORIES DIV. WYETH-AYERST PHARMACEUTICALS
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED FULL SERIES OF SYNVISC IN RIGHT KNEE - 9/13, 9/20, 9/27, 1999. 9/28 - PT CALLED IN BECAUSE THEY HAD WAKENED WITH KNEE ACUTELY SWOLLEN AND STIFFNESS, BUT NO REDNESS OR FEVER. 9/29 - PT CAME IN FOR FOLLOW-UP VISIT. PT NOW WITH SYNOVITIS FROM INJECTIONS. ASPIRATED FLUID FROM KNEE FOR AEROBIC/ANAEROBIC CULTURES. 10/4 - FOLLOW-UP VISIT: KNEE LESS SWOLLEN, REDUCED PAIN. AEROBIC/ANAEROBIC CULTURES NEGATIVE X5 DAYS, NO SYNOVIAL CRYSTALS. ASSESSMENT: ACUTE SYNOVITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC 8 MG/CC INTRAARTICULAR HYALURONIC ACID MOZ WYETH-LABORATORIES DIV. WYETH-AYERST PHARMACEUTICALS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other