BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 5873191 · Received August 12, 2016

    Report

    Report Number
    1416980-2016-14060
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    July 18, 2016
    Report Date
    August 12, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN (500 MG DAILY; ROUTE AND DURATION NOT REPORTED) FOR PERITONITIS. ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. THE PATIENT铠RECOVERY STATUS AND OUTCOME OF THE EVENT WERE UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525449 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention DIANEAL 2.5%