BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOVISC 30MG/2NL

    MDR report key: 5353539 · Received January 5, 2016

    Report

    Report Number
    MW5059076
    Event Type
    Death
    Date Received
    January 5, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 5, 2016
    Manufacturer
    JANSSEN
    Product Code
    MOZ
    UDI-DI
    59676036001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT DECEASED. DATES OF USE: (B)(6) 2013 - (B)(6) 2015. DOSE OR AMOUNT: ONE SYRINGE, WEEKLY FOR 3 WEEKS. FREQUENCY: WEEKLY FOR 3 WEEKS. ROUTE: INTRA-ARTICULARLY. DIAGNOSIS OR REASON FOR USE: OSTEOARTHRITIS OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5210 ORTHOVISC 30MG/2NL ORTHOVISC 30MG/2NL MOZ JANSSEN NA 59676036001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death