BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC

    MDR report key: 18159624 · Received November 16, 2023

    Report

    Report Number
    MW5148242
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 14, 2023
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS. PRESCRIBER CALLED INTO REPORT THAT THE NEEDLE WAS BROKEN. THEY WERE ABLE TO SEE THIS WITHOUT OPENING THE PACKAGE. INDICATION: BILATERAL PRIMARY OSTEOARTHRITIS OF KNEE. UNKNOWN IF PATIENT MISSED DOSE. NO ADVERSE EVENT REPORTED. UNKNOWN IF DEFECTIVE DEVICE ON HAND FOR RETURN. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION PROVIDED. DATE OF MALFUNCTION: 11/14/2023. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694824 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION DRSL024A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female