BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3964411 · Received June 19, 2014

    Report

    Report Number
    1049092-2014-00222
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CONVATEC INC.:
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION, AS PER REPORTS OF THE PRODUCT BEING BROKEN RIGHT OUT OF THE PACKAGE THUS NEVER USED FOR TREATMENT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BALLOON IS BROKEN, AND THAT THE SYSTEM WAS NEVER IN USE DUE TO THE BROKEN BALLOON. ADDITIONAL INFORMATION RECEIVED VIA EMAIL DATED (B)(6) 2014 STATED THAT THE PRODUCT WAS SUPPOSED TO BE USED FOR TREATMENT RELATED TO DIARRHEA. THE BREAK IS DESCRIBED AS: "IT LOOKS LIKE IT WAS KIND OF TORN AND LEFT WITH A RATHER BIG OPENING IN THE BALLOON." THE ACTUAL BROKEN COMPONENT ON THE DEVICE IS REPORTED AS FOLLOWS: "THE BALLOON/CUFF INTENDED TO BE INSIDE THE PATIENT'S RECTAL VAULT IS BROKEN" LASTLY, IT IS REPORTED THAT THE BALLOON EXPERIENCED INFLATION DIFFICULTIES RELATED TO THIS BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359387 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC.: 418000 13VM517411

    Patients

    Seq Age Sex Outcome Treatment
    1