BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 6639544 · Received June 14, 2017

    Report

    Report Number
    9612392-2017-00008
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    April 24, 2017
    Report Date
    May 18, 2017
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REPORTED AS MW5069401. IT WAS FOUND BY SEARCHING THE MAUDE ON MAY 18, AND THE NOTIFICATION LETTER FROM THE FDA WAS SENT TO OUR US REPRESENTATIVE SAME DAY. THIS IS A DEFINITIVE REPORT SINCE THE REPORTER'S CONTACT IS NOT AVAILABLE. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF BIOVENTUS LLC AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2016008.

    Description of Event or Problem · 0

    A PATIENT RECEIVED THE 1ST SUPARTZ INJECTION TO KNEE. PATIENT'S BLOOD PRESSURE WAS NORMAL. THE PATIENT RECEIVED THE 2ND SUPARTZ INJECTION. THE BLOOD PRESSURE ELEVATED TO 140/80 FROM NORMAL. ON (B)(6) 2017 - THE PATIENT RECEIVED THE 3RD SUPARTZ INJECTION. ON (B)(6) 2017 - THE BLOOD PRESSURE WAS 153/93. THE PATIENT STATED THE PATIENT HAVE ALWAYS RUN NORMAL IN BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422863 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMITREX| NEURONTIN| NORCO| PROTONIX| SINGULAIR| TOPAMAX| IMITREX| NEURONTIN| NORCO| PROTONIX| SINGULAIR| TOPAMAX