BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC ONE PFS

    MDR report key: 23077708 · Received September 17, 2025

    Report

    Report Number
    MW5176215
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 13, 2025
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) MA FROM MD OFFICE CALLED TO REPORT A DEFECTIVE DEVICE. WHEN THE BOX WAS OPENED SYRINGE WAS DAMAGED AND COMPLETELY BROKEN OFF BETWEEN THE SYRINGES AND THE NEEDLE. PATIENT HAD AN APPOINTMENT TODAY, THEY WERE ABLE TO ADMINISTER TO KNEE. UNKNOWN IF PATIENT EXPERIENCED AN ADVERSE EVENT OR IF PRODUCT AVAILABLE FOR RETURN. NO FURTHER INFORMATION PROVIDED. INDICATION: UNILATERAL PRIMARY OSTEOARTHRITIS, RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577544 SYNVISC ONE PFS ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION ERSL031B

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female