BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3083341 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10708
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH AN ABSCESS IN THE PERITONEAL CAVITY. THE PATIENT EXPERIENCED SWELLING IN THE GROIN AREA AND WAS ADMITTED TO THE HOSPITAL (DATE NOT REPORTED). UPON ADMISSION, X-RAYS NOTED THE PATIENT?S PERITONEAL DIALYSIS CATHETER HAD MOVED AWAY FROM ITS POSITION. THE X-RAY ALSO CONFIRMED AN ABSCESS IN THE PERITONEAL CAVITY. THE PATIENT WAS SUPPOSEDLY CONSTIPATED AT THE TIME OF THE CALL. THE SPOUSE REPORTED THE STAFF AT THE HOSPITAL SAID THE CONSTIPATION ISSUE MOVED THE POSITION OF THE DRAIN. THE PATIENT'S PHYSICIAN REPORTED THE PATIENT'S SWELLING IN THE GROIN AREA WAS RELATED TO THE PATIENT NOT DRAINING PROPERLY AS THE POSITION OF THE DRAIN MOVED DUE TO THE PATIENT BEING CONSTIPATED AND THE ABSCESS. THE PATIENT HAD A SURGICAL PROCEDURE TO REMOVE THE ABSCESS. THE PATIENT ALSO RECEIVED TREATMENT FOR CONSTIPATION ISSUES. THE PATIENT?S SPOUSE STATED THE PATIENT WILL REQUIRE ANOTHER OPERATION (DATE UNKNOWN) TO REPOSITION THE DRAIN TO A MORE APPROPRIATE LOCATION. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184859 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL| DIANEAL