BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3853532 · Received April 3, 2014

    Report

    Report Number
    2243969-2014-00169
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 12, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO FDA ON APRIL 3, 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 FROM A NURSE THAT THE FMS LEAKED ON A PATIENT, AND VERBALIZED ALL THE RIGHT MEANS OF INSERTION. THERE IS NO ADDITIONAL INFORMATION AND THE LOT NUMBER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201755 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1