BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 400784 · Received June 21, 2002

    Report

    Report Number
    9612392-2002-00011
    Event Type
    Injury
    Date Received
    June 21, 2002
    Date of Event
    May 8, 2002
    Report Date
    June 21, 2002
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HSD A SUPRARTZ INJECTION BY AN ORTHOPEDIC PHYSICIAN IN 2002 AT 10 AM. AT 7 AM THE FOLLOWING DAY PT BEGAN HAVING STROKE LIKE SYMPTOMS INCLUDING ITCHING, BUMPING OF THE FACE, NOSE AND CLUMSINESS OF THE RIGHT ARM. AN MRI SCAN OF THE BRAIN CONFIRMED THE PRESENCE OF AN ACUTE INFARCT IN THE LEFT BRAIN STEM. THOSE SYMPTOMS PERSIST TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA 1Z487Z

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other