BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6099644 · Received November 14, 2016

    Report

    Report Number
    1416980-2016-17213
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    October 10, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY STOMACH PAIN. THE CAUSE OF, THE TREATMENT FOR, AND THE OUTCOME OF THE PERITONITIS WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. NO FURTHER INFORMATION WAS PROVIDED REGARDING WHETHER DIANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750158 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization DIANEAL PD-4, 2.5%