BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3841814 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17517
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS LATER HOSPITALIZED FOR INFECTION COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE NATURE OF INFECTION WAS NOT REPORTED. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. THE TREATMENT AND OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318929 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL