BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1843012 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03663
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE IN (B)(6) 2006, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. ON AN UNREPORTED DATE IN 2010, THE PATIENT DEVELOPED PERITONITIS. ON AN UNREPORTED DATE IN 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, WHICH REVEALED YEAST. THE PATIENT WAS DIAGNOSED WITH A FUNGAL PERITONITIS. IT WAS NOT REPORTED IF A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED OR IF THE PATIENT RECEIVED REMEDIAL THERAPY. ON AN UNREPORTED DATE IN 2010, THE EVENT OF FUNGAL PERITONITIS RESOLVED. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED THE NURSE STATED THE EVENT OF FUNGAL PERITONITIS WAS UNRELATED TO PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR DIANEAL PD2 ULTRABAG