BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 7182183 · Received January 11, 2018

    Report

    Report Number
    9612392-2018-00001
    Event Type
    Injury
    Date Received
    January 11, 2018
    Date of Event
    December 4, 2017
    Report Date
    December 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 A STAFF OF PHYSICIAN'S CLINIC AND THE PHYSICIAN CONFIRMED THE EVENT. ACCORDING TO THE PHYSICIAN'S STAFF, THEY WERE WONDERING IF THE INJECTION WAS POSSIBLY CONTAMINATED, BECAUSE THEY WERE UNSURE OF WHY HE GOT SO ILL. INJECTION PHYSICIAN STATED IT WAS VERY UNLIKELY THAT THE INJECTION WAS CONTAMINATED OR THAT IT CAUSED HIS INFECTIONS. 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 NO.4X7C29. FURTHERMORE, NO INFECTIOUS EVENT HAS BEEN REPORTED FROM OTHER FACILITIES IN THE US EXCEPT FOR THIS CASE, THE URINARY TRACT INFECTION WAS THEREFORE NOT RELATED TO PRODUCT QUALITY. IT WAS CONSIDERED THAT THE CAUSAL RELATIONSHIP WAS "NOT RELATED" BECAUSE COMMUNITY-ACQUIRED INFECTION COULD BE SUSPECTED. 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) 2017 - A MALE PATIENT RECEIVED 1ST INJECTION OF SUPARTZ FX TO THE KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2017 - HE RECEIVED 2ND INJECTION OF SUPARTZ FX. ON (B)(6) 2017 - HE RECEIVED 3RD INJECTION OF SUPARTZ FX. ON (B)(6) 2017 - HE RECEIVED 4TH INJECTION OF SUPARTZ FX. HE WAS VOMITING AT NIGHT. ON (B)(6) 2017 - HE ENDED UP IN THE ER WITH A FEVER. HE WAS DIAGNOSED WITH E.COLI AND AN URINARY TRACT INFECTION. ON (B)(6) 2017 - HE WAS TAKING MEDICATIONS THAT WERE PRESCRIBED. HE WAS FEELING A LITTLE BIT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26470 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01 4X7C29

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization