BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC 8MG/CC

    MDR report key: 277166 · Received May 4, 2000

    Report

    Report Number
    MW1018850
    Event Type
    Other
    Date Received
    May 4, 2000
    Date of Event
    February 13, 1999
    Report Date
    May 4, 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 (X3 DOSES) OF SYNVISC IN LEFT KNEE. THEY RECEIVED THE LAST DOSE OF SYNVISC ON 2/10/99. THEY CALLED ON 2/13 COMPLAINING OF INCREASED PAIN, SWELLING, AND STIFFNESS IN THEIR KNEE. THEY HAVE BEEN FEBRILE "OFF AND ON" SINCE MORNING 2/13. SEEN ON 2/19 IN CLINIC FOR EVALUATION OF LEFT KNEE. THERE WAS NO FLUID ASPIRATED, NO ERYTHEMA, NOT SUGGESTIVE OF INFECTION, BUT SLIGHT EFFUSION. ASSESSMENT: ACUTE SYNOVITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other