BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 636428 · Received September 20, 2005

    Report

    Report Number
    2246315-2005-00096
    Event Type
    Injury
    Date Received
    September 20, 2005
    Date of Event
    August 1, 2005
    Report Date
    September 2, 2005
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO WAS REC'D IN 09/2005 FROM A PHYSICIAN VIA A SALES REPRESENTATIVE REGARDING A PT WITH UNKNOWN MEDICAL HISTORY AND PRIOR SYNVISC INJECTIONS SIX MONTHS AGO. THE PT EXPERIENCED LARGE EFFUSION IN ONE KNEE AND HIGH WHITE BLOOD CELL COUNT. THE PT COMPLETED FIRST AND SECOND INJECTIONS IN 08/2005. THE PT REC'D TWO INJECTIONS OF SYNVISC INTO AN UNSPECIFIED KNEE IN 08/2005. WITHIN 24 HOURS AFTER THE PT'S SECOND INJECTION, PT HAD A LARGE EFFUSION IN THE KNEE. THE KNEE WAS ASPIRATED AND 100CC OF FLUID WAS REMOVED. THE SYNOVIAL FLUID HAD A HIGH WHITE BLOOD CELL COUNT BUT THE CULTURE TAKEN WAS NEGATIVE. THE PT WAS GIVEN A STEROID INJECTION AND THE EVENT RESOLVED WITHIN FIVE DAYS. AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION NA N0516

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R