BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 8488200 · Received April 5, 2019

    Report

    Report Number
    9612392-2019-00003
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 13, 2019
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. 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 LOT# 4X8A19. FURTHERMORE, NO INFECTIOUS EVENT HAS BEEN REPORTED FROM OTHER FACILITIES IN THE US EXCEPT FOR THIS CASE, THE INFECTION WAS THEREFORE NOT RELATED TO PRODUCT QUALITY. 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

    ON (B)(6) 2019- A (B)(6) YEAR-OLD MALE PATIENT RECEIVED SUPARTZ FX INJECTION FOR OSTEOARTHRITIS. ON (B)(6) 2019 - HE REQUIRED SURGERY DUE TO INFECTION IN JOINT FROM INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278995 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01 4X8A19

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other