BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 505413 · Received January 8, 2004

    Report

    Report Number
    2246315-2004-00002
    Event Type
    Injury
    Date Received
    January 8, 2004
    Report Date
    January 7, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN DEC. 2003 ADDITIONAL CLARIFICATION WAS PROVIDED BY THE AUTHOR/TREATING PHYSICIAN WHICH VERIFIED THAT THIS PT HAD NOT BEEN PREVIOUSLY REPORTED TO GENZYME. THE ARTICLE INDICATED THAT AN UNIDENTIFIED PT RECEIVED A SECOND COURSE OF SYNVISC INJECTIONS AND EXPERIENCED A SEVERE SYNOVIAL FLARE (SEVERE ARTHROSIS). THE AUTHOR REPORTS THAT IN GENERAL, IN PTS WITH A MORE SEVERE REACTION OR POST INJECTION FLARE, ITS ONSET OCCURS WITHIN 12-36 HOURS AFTER THE INJECTION AND TYPICALLY RESOLVES WITHIN 48 HOURS AFTER TREATMENT WITH ASPIRATION AND INTRA-ARTICULAR STEROIDS. THE TREATING PHYSICIAN ASSESSED THE EVENT AS SERIOUS, SEVERE AND POSSIBLY RELATED TO THE USE OF SYNVISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention