BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 8962481 · Received September 4, 2019

    Report

    Report Number
    3009211636-2019-00195
    Event Type
    Death
    Date Received
    September 4, 2019
    Date of Event
    November 1, 2018
    Report Date
    September 4, 2019
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE PERCUTANEOUS TRANSHEPATIC TUNNELLED CATHETER FOR HAEMODIALYSIS: A SINGLE CENTRE EXPERIENCE SOURCE KIDNEY INTERNATIONAL REPORTS, VOLUME 4, 2019 (S357-S358). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JANUARY 2016 AND NOVEMBER 2018 ON A STUDY REGARDING PERCUTANEOUS TRANSHEPATIC TUNNELED CATHETERS FOR HAEMODIALYSIS. OUT OF 8 (EIGHT)PATIENTS, 1 DIED WITH A FUNCTIONAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753888 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death