BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3795675 · Received April 25, 2014

    Report

    Report Number
    2243969-2014-00201
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 18, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS BEING REPORTED A S A DEATH BASED ON THE REPORT THAT THE PT EXPIRED A FEW DAYS LATER AFTER AN EMERGENCY COLOSTOMY WAS PERFORMED. THERE IS NO OTHER INFO AVAILABLE AT THIS TIME. NO INFO NO AMOUNT OF MLS IN BALLOON WHEN IT WAS REMOVED. PRODUCT WAS DISCARDED, THEREFORE, LOT NUMBER WAS NOT AVAILABLE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFR SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. CONVATEC WILL CONTINUE TO TRACT AND MONITOR SUCH COMPLAINTS ACCORDING TO ITS COMPLAINT HANDLING AND CAPA PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED OF THE PT'S DEATH AFTER HAVING AN FMS DEVICE INSERTED. THE REPORT INDICATED THAT A TERMINALLY ILL PT WITH MANY HEALTH ISSUES WAS WEANED OFF A VENTILATOR. AN FMS WAS IN PLACE FOR SEVERAL DAYS BUT THE PT WAS DELIRIOUS AND PULLED OUT THE FMS CAUSING MUCOSAL LACERATIONS. THE NURSE DID NOT PROVIDE DESCRIPTION; SIZE OR IF ANY BLEEDING WAS NOTED. AN EMERGENCY COLOSTOMY WAS PERFORMED AND THE PT EXPIRED A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251318 FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC, INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R