BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6212374 · Received December 29, 2016

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    Report

    Report Number
    1416980-2016-18857
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 3, 2016
    Report Date
    December 29, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT RENDERED FOR THE EVENT AND THE PATIENT¿S OUTCOME WERE NOT REPORTED. THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862002 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization DIANEAL 2.5%| DIANEAL 4.25%