BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1819070 · Received August 27, 2010

    Report

    Report Number
    1423500-2010-02987
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 10, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(4) OF PERITONITIS IN AN ADULT PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT WAS OTHERWISE CLINICALLY ASYMPTOMATIC. THE PATIENT WAS NOT TREATED WITH ANTIBIOTICS. ON (B)(6) 2010, EXTRANEAL THERAPY WAS STOPPED. ON (B)(6) 2010, 24 HOURS AFTER EXTRANEAL WAS STOPPED, THE STERILE PERITONITIS RESOLVED. ON AN UNREPORTED DATE, EXTRANEAL THERAPY RESTARTED WITH A DIFFERENT BATCH NUMBER. THE STERILE PERITONITIS DID NOT RETURN. PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT'S PERITONEAL EFFLUENT LEUCOCYTE COUNT WAS NORMAL, THE EFFLUENT WAS CLEAR, AND THE PATIENT WAS ASYMPTOMATIC.

    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 Required Intervention PHYSIONEAL AND NUTRINEAL PD4, EXTRANEAL VIAFLEX