BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3769638 · Received April 17, 2014

    Report

    Report Number
    2243969-2014-00187
    Event Type
    Death
    Date Received
    April 17, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS BEING REPORTED AS A DEATH, HOWEVER, CUSTOMER STATED THAT THERE WAS NO ADVERSE EVENT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONVATEC TERRITORY MANAGER ON (B)(4) 2014 INDICATING THAT "...THERE WAS NO ADVERSE EVENT WITH THE FLEXISEAL". IN ADDITION, THE REPORTER REQUESTED THAT "...WE DO NOT CALL THEM ANYMORE ON THIS ISSUE." THE TM INDICATED THAT THERE WAS A "MISCOMMUNICATION" FROM THE CUSTOMER. NO ADDITIONAL PT/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. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ISSUE OCCURRED SOMETIME IN (B)(6) 2014 REGARDING OVER INFLATION (IN EXCESS OF 200 ML) OF THE DEVICE CAUSING EROSION THROUGH THE RECTUM. ULTIMATELY, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236527 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC, INC. 418000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| L| R