BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6112976 · Received November 18, 2016

    Report

    Report Number
    1416980-2016-17456
    Event Type
    Injury
    Date Received
    November 18, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 PATIENT EXPERIENCED SUSPECTED PERITONITIS. THE CAUSE OF THE SUSPECTED PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT RENDERED FOR THE EVENT AND RECOVERY STATUS WERE NOT REPORTED. THE ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763609 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization DIANEAL PD4 1.5%