BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3988018 · Received May 29, 2014

    Report

    Report Number
    1049092-2014-00136
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K1112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFO 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 WAS REPORTED THAT AFTER FOUR (4) HOURS, APPLIANCE WAS REMOVED RELATED TO LEAKAGE ON THE BALLOON. ADDITIONAL INFO RECEIVED INDICATED THAT A DEVICE WAS REPLACED WITH ANOTHER PRODUCT (TYPE UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317538 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES; 78KNT KNT CONVATEC INC 411107 13FM0308

    Patients

    Seq Age Sex Outcome Treatment
    1