BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 8537827 · Received April 22, 2019

    Report

    Report Number
    3009211636-2019-00098
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE PRELIMINARY REPORT: CYSTOSCOPY-ASSISTED PERITONEAL DIALYSIS CATHETER PLACEMENT ¿ A DIRECT, VISUAL, SAFE, PRECISE, EASY, MINIMALLY INVASIVE, AND INEXPENSIVE TECHNIQUE SOURCE CLINICAL NEPHROLOGY, VOLUME 81, 2014 (247-250) ARTICLE NUMBER: 4 DATE OF PUBLICATION: 12 MARCH 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2009 TO NOVEMBER 2012. 29 PATIENTS WITH ESRD UNDERWENT PD CATHETER PLACEMENT, 14 PATIENTS UNDERWENT CYSTOSCOPY-ASSISTED SURGERY (GROUP A) AND THE REMAINING 15 PATIENTS UNDERWENT CONVENTIONAL OPEN SURGERY (GROUP B) FOR PLACEMENT OF THE STANDARD DOUBLE-CUFF SWAN-NECK PD CATHETER. SURGICAL COMPLICATIONS IN THE TWO STUDY GROUPS: CATHETER OBSTRUCTION 0 (0%) 1 (6.7%), CATHETER MIGRATION 0 (0%) 1 (6.7%), DIALYSATE LEAK 0 (0%) 2 (13.4%), SITE INFECTION 0 (0%) 1(6.7%), PERITONITIS 1 (7.1%) 5 (33.3%), HERNIA 0 (0%) 2 (13.4%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331061 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention