BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10098825 · Received May 28, 2020

    Report

    Report Number
    1416980-2020-02987
    Event Type
    Injury
    Date Received
    May 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: WONG, H., ONG, L., LIM, T., HOOI, L., MORAD, Z., GHAZALLI, R., SHAARIAH, W., LIM, Y., AHMAD, G., BAK-LEONG GOH, M., LIAW, L., PEE, S., LEE, M. ¿A RANDOMIZED, MULTICENTER, OPEN-LABEL TRIAL TO DETERMINE PERITONITIS RATE, PRODUCT DEFECT, AND TECHNIQUE SURVIVAL BETWEEN ANDY-DISC AND ULTRABAG IN PATIENTS ON CAPD¿. AMERICAN JOURNAL OF KIDNEY DISEASES, VOL 48, NO 3 (SEPTEMBER), 2006: PP 464-472. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A STUDY WAS PERFORMED IN WHICH 43 PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE PERITONITIS EVENTS WAS NOT REPORTED. PATIENT OUTCOMES WERE NOT REPORTED. ACTION WITH PD WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562128 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other