BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC INJ 8MG/ML(3X2ML)*

    MDR report key: 9967505 · Received April 15, 2020

    Report

    Report Number
    MW5094158
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE OF THE PFS OF SYNVISC WAS DEFECTIVE. DATES OF USE: (B)(6) 2020 TO PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429569 SYNVISC INJ 8MG/ML(3X2ML)* ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR