BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC 8 MG/CC

    MDR report key: 277172 · Received May 3, 2000

    Report

    Report Number
    MW1018851
    Event Type
    Injury
    Date Received
    May 3, 2000
    Date of Event
    August 3, 1998
    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

    7/22 - PT RECEIVED 1ST DOSE OF SYNVISC IN LEFT KNEE. 7/29 - PT RECEIVED 2ND DOSE OF SYNVISC. 8/3 - PT CALLED COMPLAINING OF HIVES ON BUTTOCKS, FACE, BEHIND EARS AND ON THIGHS, AND DIFFICULTY BREATHING. PT WAS RX'D WITH BENADRYL 25 MG 1-2 CAPSULES Q4-6H PRN. PT ALSO HAD EPIPEN ON HAND IF HAVING MORE DIFFICULTY WITH BREATHING. 8/5 - PATIENT RECEIVED 3RD DOSE OF SYNVISC. 8/10 PT BEGAN HAVING CHILLS, WELTS AND HIVES ALL OVER BODY, ANXIETY. PT DENIES SWELLING OF KNEE, RED OR HOT TO TOUCH. PT WAS RX'D WITH ALLEGRA Q12H WITH SOME RELIEF. ASSESSMENT: URTICARIA SECONDARY TO SYNVISC INJECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention