BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPARTZ FX

    MDR report key: 5740704 · Received June 22, 2016

    Report

    Report Number
    9612392-2016-00009
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 20, 2016
    Report Date
    May 25, 2016
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. OUR MEDICAL DOCTOR'S COMMENT: ACCORDING TO THE REPORT, HIVES/RASH OVER THE ENTIRE BODY AND LIP SWELLING DEVELOPED THREE HOURS AFTER THE INITIAL SUPARTZ INJECTION, AND THE PATIENT RECOVERED AFTER THE TREATMENT WITH A STEROID INJECTION. THE PATIENT IS ALLERGIC TO ALEVE (NAPROXEN SODIUM), MINOCIN (MINOCYCLINE HYDROCHLORIDE) AND SHELLFISHES, BUT THERE IS NO INFORMATION ABOUT CONCOMITANT DRUGS. ALTHOUGH THERE IS A POSSIBILITY THAT THIS EVENT IS AN ACCIDENTAL REACTION CAUSED BY FOODS, ETC., A RELATION WITH SUPARTZ CANNOT BE COMPLETELY RULED OUT.

    Description of Event or Problem · 0

    ON (B)(6) 2016 A (B)(6) YEAR-OLD FEMALE PATIENT RECEIVED 1ST SUPARTZ INJECTION AND WITHIN THREE HOURS DEVELOPED HIVES/RASH OVER ENTIRE BODY AND LIP SWELLING. THE PATIENT LATER WENT TO URGENT CARE AND WAS GIVEN A STEROIDS INJECTION IN HER BUTTOCKS AND WAS GIVEN A MEDROL DOSE PACK. THE PATIENT ISSUES LATER RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395918 SUPARTZ FX ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION 89130-4444-01 5H845N

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other