BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3921527 · Received June 9, 2014

    Report

    Report Number
    1049092-2014-00190
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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 APPROXIMATELY ONE AND ONE-HALF MONTHS AGO WHILE REMOVING THE FMS SIGNAL FROM THE PATIENT (WHO IS DESCRIBED AS A LARGE MAN WITH INTERNAL HEMORRHOIDS) EXPERIENCED DEFLATION DIFFICULTIES WITH THE GMS SIGNAL BALLOON. THE COMPLAINT STATES THAT THE NURSE THOUGHT THE BALLOON MAY HAVE BEEN OVER-INFLATED, AND THAT NURSE WAS ABLE TO REMOVE FLUID FROM THE BALLOON (AMOUNT UNKNOWN) RESULTING IN THE ABILITY TO REMOVE THE BALLOON FROM THE ANUS WHILE PARTIALLY INFLATED (AMOUNT OF REMAINING MLS IN THE BALLOON IS UNKNOWN). NO TRAUMA WAS NOTED TO THE PATIENT AND NO UNTOWARD EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334566 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1