BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 12088416 · Received June 28, 2021

    Report

    Report Number
    MW5102203
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 28, 2021
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT SHE HAS HAD CONSISTENT, SEVERE DAILY PAIN THAT IS NINE OUT OF TEN ON THE PAIN SCALE. HAS HAD A TOTAL OF THREE INJECTIONS OF SYNVISC AND HAS NOT BEEN ABLE TO BE ACTIVE OR RIDE HER BICYCLE SINCE HER FIRST INJECTION. REPORTER STATES THAT THE INJECTION WAS RECALLED SOME YEARS AGO DUE TO INFECTION REASONS AND WAS NOW BACK ON THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978047 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION
    978048 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION
    978049 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other