BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 23885985 · Received December 23, 2025

    Report

    Report Number
    9610987-2025-00029
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 20, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLERGIC REACTION (ITCHING) EXPERIENCED DURING TREATMENT. OCCURRED A TOTAL OF 6 TIMES WITH THE SAME PATIENT. MEDICAL INTERVENTION: CLEMASTINE, DIMETHINDENE, AND DIFELIKEFARIN INTRAVENOUS INJECTION WERE ADMINISTERED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ALLERGIC REACTION (ITCHING) EXPERIENCED DURING TREATMENT. OCCURRED A TOTAL OF 6 TIMES WITH THE SAME PATIENT. MEDICAL INTERVENTION: CLEMASTINE, DIMETHINDENE, AND DIFELIKEFARIN INTRAVENOUS INJECTION WERE ADMINISTERED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802338 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-17H 25E12K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other