BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO

    MDR report key: 24189724 · Received January 27, 2026

    Report

    Report Number
    9612392-2026-00002
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    November 30, 2025
    Report Date
    January 27, 2026
    Manufacturer
    SEIKAGAKU CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P980044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DEFINITIVE REPORT. THIS CASE WAS REPORTED BY A HOSPITAL TO CHINESE AUTHORITY, THE CHINESE SALES PARTNER RECEIVED IT ON 2026-01-08 AND FORWARDED IT TO THE MANUFACTURER ON 2026-01-09. THE MANUFACTURER CONFIRMED RECEIPT ON 2026-01-13. NO FURTHER INFORMATION WAS PROVIDED BY THE REPORTER. THE PHYSICIAN'S CAUSALITY ASSESSMENT WAS DETERMINED AS "POSSIBLE". COMPANY COMMENT: MANUFACTURER'S CAUSALITY ASSESSMENT WAS DETERMINED AS "POSSIBLE" TO OUR PRODUCT; ARTZ DISPO, CONSIDERING THE TIME COURSE OF THE EVENTS AND THE REPORTER'S CAUSALITY ASSESSMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025 - THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "HAVING EXPERIENCED ELEVATED BLOOD SUGAR FOR OVER 15 YEARS, EXCESSIVE THIRST, FREQUENT URINATION, DRY MOUTH, WEIGHT LOSS, AND LEFT SHOULDER PAIN FOR HALF A YEAR". ON (B)(6) 2025 - AFTER CONSULTATION BY THE MEDICAL REHABILITATION DEPARTMENT, THE DIAGNOSIS WAS: LEFT FROZEN SHOULDER. ON (B)(6) 2025 - RECEIVING SODIUM HYALURONATE INJECTION TREATMENT. ON (B)(6) 2025 - THE PATIENT DEVELOPED SKIN ITCHING AND SCATTERED RASHES ON THE LIMBS AND ANTERIOR TRUNK. A CONSULTATION WITH THE DERMATOLOGY DEPARTMENT WAS REQUESTED TO CONSIDER: DRUG ERUPTION. THE SUSPECTED DRUGS WERE DISCONTINUED, AND ANTI-ALLERGIC TREATMENT WITH COMPOUND GLYCYRRHIZIN, CALCIUM GLUCONATE, AND DESLORATADINE WAS INITIATED. THE SYMPTOMS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252401 ARTZ DISPO ACID, HYALURONIC, INTRAARTICULAR MOZ SEIKAGAKU CORPORATION NA 4C4X08

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other LIDOCAINE HYDROCHLORIDE (0.1G)