BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC 8 MG/ML

    MDR report key: 277199 · Received May 1, 2000

    Report

    Report Number
    MW1018854
    Event Type
    Injury
    Date Received
    May 1, 2000
    Date of Event
    April 7, 1999
    Report Date
    May 1, 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

    4/7 - PT RECEIVED ONE INJECTION OF SYNVISC IN RIGHT KNEE, AND DEVELOPED PAIN IN THE KNEE THE SAME EVENING. 4/9 - PT WENT IN FOR FOLLOW UP VISIT WITH ORTHO. RIGHT KNEE DEVELOPED EFFUSION 20-30 CC, NO ERYTHEMA, ROM 0-135 DEGREES WITHOUT SIGNIFICANT PAIN. 4/13 - FOLLOW UP VISIT: PAIN AND SWELLING OF RIGHT KNEE RESOLVING, NO ERYTHEMA, ROM 0-120 DEGREES WITH PAIN AT MAXIMUM FLEXION. RESIDUAL EFFUSION 30CC. DIAGNOSIS: ACUTE SYNOVITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention