BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC-ONE

    MDR report key: 22545312 · Received July 18, 2025

    Report

    Report Number
    MW5172941
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    July 15, 2025
    Report Date
    July 16, 2025
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SYNVISC SINGLE DOSE SYRINGE BROKE AT THE BASE WHERE THE 22GAUGE NEEDLE WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784666 SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION FRSLB11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown HYLAN G-F 20