BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNVISC

    MDR report key: 10828834 · Received November 10, 2020

    Report

    Report Number
    MW5097772
    Event Type
    Death
    Date Received
    November 10, 2020
    Date of Event
    February 25, 1998
    Report Date
    April 16, 1998
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED FIRST OF THREE INJECTABLE TREATMENT WITH SYNVISC ON (B)(6). SECOND INJECTION WAS GIVEN ON (B)(6) 1998. THE PATIENT RECEIVED THE INJECTION AT APPROXIMATELY 1:45 PM. THE PATIENT RETURNED TO THE NURSING HOME AND REPORTED NAUSEA AT 4 PM (NOT AN UNUSUAL COMPLAINT ACCORDING TO REPORTER). THE PATIENT WAS CHECKED AT 8:30 PM AND COMPLAINED OF NAUSEA. THE PATIENT WAS FOUND DEAD AT 10:10 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279608 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION H714
    1279609 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death