BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 6561794 · Received May 11, 2017

    Report

    Report Number
    9612392-2017-00007
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 10, 2017
    Report Date
    April 14, 2017
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. SEIKAGAKU CORPORATION IS ALSO SUBMITTING THIS REPORT ON BEHALF OF BIOVENTUS LLC AS THE IMPORTER WITH AUTHORIZATION BY THE EXEMPTION NUMBER E2016008. ACCORDING TO THE RESULT OF INVESTIGATION, THERE WERE NO DEVIATIONS OR OUT-OF-SPECIFICATIONS FOUND IN THE MANUFACTURING PROCESS, THE IN-PROCESS TESTING, THE RELEASE TESTING, AND THE ENVIRONMENTAL MONITORING FOR THE LOT #4X6J08. FURTHERMORE, NO ADVERSE EVENT HAS BEEN REPORTED IN THE SAME LOT FROM OTHER FACILITIES EXCEPT FOR THIS CASE.

    Description of Event or Problem · 0

    (B)(6) 2017 - A (B)(6) YEAR-OLD MALE PATIENT RECEIVED 1ST INJECTION OF SUPARTZ FX TO THE KNEE FOR SEVERE OSTEOARTHRITIS. (B)(6) 2017 - HE RECEIVED 2ND INJECTION OF SUPARTZ FX;. (B)(6) 2017 - HE RECEIVED 3RD INJECTION OF SUPARTZ FX.; (B)(6) 2017 - HE RECEIVED 4TH INJECTION OF SUPARTZ FX.; (B)(6) 2017 - HE HAD ACUTE EMBOLISM AND DEEP VEIN THROMBOSIS OF THE LOWER EXTREMITY. HE WAS ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343333 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01 4X6J08

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization