BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNVISC 16MG/2ML

    MDR report key: 6529352 · Received April 26, 2017

    Report

    Report Number
    MW5069375
    Event Type
    Death
    Date Received
    April 26, 2017
    Date of Event
    April 20, 2017
    Report Date
    April 26, 2017
    Manufacturer
    SANOFI/GENZYME
    Product Code
    MOZ
    UDI-DI
    58468009001
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT'S WIFE REPORTED THAT THE PATIENT PASSED AWAY. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF DEATH. DOSE OR AMOUNT: 16MG. FREQUENCY: WEEKLY FOR 3 WEEKS. ROUTE: INTRA-ARTICULAR. DATES OF USE: (B)(6) 2017 - ONGOING. DIAGNOSIS OR REASON FOR USE: UNILATERAL PRIMARY OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306367 SYNVISC 16MG/2ML SYNVISC 16MG/2ML MOZ SANOFI/GENZYME 5RSP0020 58468009001

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death