BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3902993 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20893
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    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 EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH CLINDAMYCIN TABLETS 300MG (PREVIOUSLY CAPTURED AS 300GM) THREE TIMES PER DAY (ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT (PREVIOUSLY REPORTED AS RECOVERING). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT (PREVIOUSLY UNKNOWN). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH CLINDAMYCIN TABLET (300 GM, THREE TIMES A DAY, ROUTE OF ADMINISTRATION WAS NOT REPORTED) AND DRESSING TWICE A DAY WITH HYPOTONIC SOLUTION (DETAILS UNSPECIFIED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379533 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIANEAL 1.5% AND 2.5% ULTRABAG