BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3993984 · Received July 24, 2014

    Report

    Report Number
    1049092-2014-00340
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    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 ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. REPORTED TO FDA ON (B)(4) 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 THAT THE BALLOON WOULD NOT STAY INFLATED AT THE START RESULTING IN THE DISCONTINUATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435243 FLEXI-SEAL FMS FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1