BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4163845 · Received July 17, 2014

    Report

    Report Number
    1049092-2014-00312
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 24, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    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. 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. 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 CONVATEC EMPLOYEE REALIZED THAT THE LUER CONNECTOR OF THE INFLATION PORT PRESENTED ISSUE, WHILE TRYING TO DEFLATE THE BALLOON SHE HAD DIFFICULTY REMOVING THE LIQUID FROM THE BALLOON. SHE NOTICED THAT THERE WAS PRESSURE, BUT WAS ABLE TO DEFLATE THE BALLOON WITH DIFFICULTIES. IT IS FURTHER REPORTED THAT THE DEVICE WAS USED IN THE PATIENT FOR ONE (1) DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420836 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 411100 13VM507072

    Patients

    Seq Age Sex Outcome Treatment
    1