BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ

    MDR report key: 503116 · Received December 29, 2003

    Report

    Report Number
    9612392-2003-00009
    Event Type
    Injury
    Date Received
    December 29, 2003
    Date of Event
    November 19, 2003
    Report Date
    December 29, 2003
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2003, A DR'S ASSISTANT INJECTED THE FIRST SUPARTZ TO A PT. AFTER THE INJECTION, THE PT EXPERIENCED SWELLING AND PAIN THROUGH ENTIRE LEG. ONE WEEK LATER, THEY RECEIVED THE SECOND INJECTION, AND THE SWELLING AND PAIN GOT WORSE. AT THAT POINT THE DR'S ASSISTANT TOLD THE PT TO GO TO AN EMERGENCY ROOM. THE PT WAS DIAGNOSED WITH A BLOOD CLOT AT THE EMERGENCY ROOM. NO INFO ABOUT MEDICAL TREATMENT AT THE EMERGENCY ROOM IS AVAILABLE, BUT THE PT RECOVERED AND IS DOING FINE NOW. THE DR STATED IN GENERAL THAT ANYTIME YOU GIVE AN INJECTION, YOU RUN THE RISK OF BLOOD CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPARTZ SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA 3B743Z

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other