BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3120743 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12960
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONEAL SCLEROSIS AND WAS HOSPITALIZED. THE TREATMENT FOR PERITONEAL SCLEROSIS WAS TO DISCONTINUE PERITONEAL DIALYSIS THERAPY. TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222517 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG