BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3082223 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10638
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS AND CONSTIPATION IN A PATIENT COINCIDENT WITH EXTRANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). EXTRANEAL THERAPY WAS ONGOING. THE PATIENT WAS CONSTIPATED WHICH CAUSED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION (INJ). REFLIN (1GM, ONCE IN A DAY, AND ROUTE NOT REPORTED) AND INJ. FORTUM (1GM, ONCE IN A DAY, ROUTE NOT REPORTED) FOR PERITONITIS. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185117 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention EXTRANEAL