BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC-ONE

    MDR report key: 20963102 · Received December 18, 2024

    Report

    Report Number
    20963102
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 11, 2024
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING SYNVISC-ONE INJECTION, I COULD HEAR ¿CRUNCHING¿ TYPE SOUND WITH THE INJECTION. THE FLUID BEING ADMINISTERED WAS THE STANDARD VISCOUS FLUID WITHOUT RESISTANCE. UPON COMPLETION OF INJECTION, I COULD SEE CRYSTALIZED MATERIAL IN THE SYRINGE. THE INJECTION WASN¿T EXPIRED AND BOX WAS SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456983 SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION ERSL016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female