BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3960802 · Received June 10, 2014

    Report

    Report Number
    1049092-2014-00201
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADD'L INFO RECEIVED VIA EMAIL DATED (B)(6) 2014 STATING THAT "THERE IS A THIRD FMS SIGNAL INSERTED, WHICH WENT WELL." NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. 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 UPON INSERTION OF THE FMS DEVICE THE BALLOON SNAPPED. A SECOND FMS DEVICE WAS INSERTED AND THAT BALLOON SNAPPED AS WELL. PLEASE NOTE: THERE WERE TWO DEVICE THAT FAILED UPON INSERTION. THIS REPORT REPRESENTS INSTANCE #1 AND IS RELATED TO PT IDENTIFIER # (B)(6) AND MFG REPORT #1049092-2014-00202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337260 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC 418000 13VM516883

    Patients

    Seq Age Sex Outcome Treatment
    1