BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC INJ 8MG/ML (3X2ML)

    MDR report key: 8155099 · Received December 11, 2018

    Report

    Report Number
    MW5082045
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    GENZYME CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER (B)(6) PRAC SPEC- VERIFIED OFF LABEL USE FOR ANKLE-SYNVISC-INJ 1 SYR LA LEFT ANKLE WEEKLY FOR 3 WEEKS GMD, QTY 3 (1 BOX) RFL 0 . DATES OF USE: PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993657 SYNVISC INJ 8MG/ML (3X2ML) ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR