BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC 8 MG/CC

    MDR report key: 277187 · Received May 3, 2000

    Report

    Report Number
    MW1018853
    Event Type
    Other
    Date Received
    May 3, 2000
    Date of Event
    January 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 SERIES OF SYNVISC ON LEFT KNEE. PT DEVELOPED SIGNIFICANT SWELLING AND PAIN IN KNEE AFTER FIRST INJECTION OF SYNVISC ON 1/27/99. PT WENT ON TRIP IN BETWEEN FIRST AND SECOND INJECTION, SO DID NOT COME IN FOR FOLLOW-UP VISIT. SYMPTOMS RESOLVED, AND PT RECEIVED SECOND AND THIRD INJECTION OF SYNVISC, 2/3 AND 2/10, 1999, RESPECTIVELY. NO INTERVENTION WAS REQUIRED. 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 58 YR Other