BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 7011785 · Received November 8, 2017

    Report

    Report Number
    9612392-2017-00011
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    October 12, 2017
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. THIS WAS REPORTED FROM THE PATIENT'S RELATIVE AND FURTHER INFORMATION WAS NOT AVAILABLE. IT WAS CONSIDERED THAT THE EVENT COULD BE POSSIBLLY RELATED TO THE INJECTION BUT ALSO RELATED TO THE PATIENT'S CONDITION BECAUSE THE EVENT OCCURRED 1 WEEK AFTER THE INJECTION. 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

    (B)(6) 2017 - A MALE PATIENT RECEIVED 5 INJECTIONS OF SPARTZ WEEKLY FOR OSTEOARTHRITIS. (B)(6) 2017- HE DEVELOPED SEVERE HIVES ON HIS LEGS 1 WEEK AFTER THE LAST INJECTION. THEY WERE SO BAD, HE ENDED UP IN THE HOSPITAL FOR SEVERAL DAYS. THEY WERE TRYING TO FIND A CAUSE AND THAT IS THE ONLY THING THAT WAS DONE TO HIS BODY. (B)(6) 2017 - HE WAS OUT OF THE HOSPITAL BUT THE HIVES CAME BACK AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789033 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization