BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE

    MDR report key: 20687296 · Received November 13, 2024

    Report

    Report Number
    MW5162522
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 12, 2024
    Manufacturer
    SANOFI / GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING SYNIVSC 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. LOT: ERSL016, EXP: 2027-03. RIGHT KNEE OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169152 SYNVISC ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI / GENZYME CORPORATION ERSL016

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female