BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4163844 · Received July 17, 2014

    Report

    Report Number
    1049092-2014-00316
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE 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. ADDITIONAL INFORMATION RECEIVED VIA EMAIL DATED (B)(6) 2014 CONTAINING PHOTOGRAPHIC IMAGES SHOWING EVIDENCE OF THE BROKEN PART OF THE FMS DEVICE. 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 PART OF THE FMS STANDARD DEVICE WHERE THE BALLOON IS FILLED, SPONTANEOUSLY BROKE RESULTING FORM THE PATIENT TURNING SUDDENLY IN BED. IT IS FURTHER REPORTED THAT BROKEN PIECES WAS FOUND IN THE BED. LASTLY, THE BALLOON WAS DEFLATED RESULTING IN SUCCESSFUL REMOVAL OF THE DEVICE FROM PATIENT WHO SUFFERED NO INJURIES; IN ADDITION A NEW FMS WAS INSERTED WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420742 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 411100 13FM0002

    Patients

    Seq Age Sex Outcome Treatment
    1