BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 4027631 · Received August 4, 2014

    Report

    Report Number
    1049092-2014-00395
    Event Type
    Death
    Date Received
    August 4, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS BEING REPORTED AS A DEATH. THE NURSE INDICATED THIS WAS ALL THE INFORMATION SHE REMEMBERED BECAUSE THE EVENT OCCURRED SO MANY YEARS PAST. ADDITIONAL PT/EVENT DETAILS HAVE BEEN REQUESTED, NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOMES 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE THE TERRITORY MANAGER WAS PERFORMING IN-SERVICING ON (B)(6) 2014, THE REPORTER WHO WAS A STAFF NURSE AT THE FACILITY ABOUT 5-6 YEARS AGO INDICATED THAT SHE HAD A FEMALE PT, (UNK DIAGNOSIS FOR ADMITTANCE AND CO-MORBIDITIES) WHO DEVELOPED A BLEED ASSOCIATED WITH PRESSURE FROM THE FMS TUBES, AS REVEALED BY RESULTS FROM LAB WORK AND EVIDENCE BY STAFF AND DOCTORS; HOWEVER, IT IS NOT KNOWN WHERE THE BLEED ORIGINATED. IT IS FURTHER REPORTED THAT THE PT BECAME MORE CRITICAL AND HAD TO BE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). LASTLY, IT IS REPORTED THAT THE PT DID EXPIRE; HOWEVER SINCE THE REPORTING NURSE DID NOT FOLLOW THE PT SHE IS UNAWARE OF THE FINAL DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455404 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES, 78 KNT KNT CONVATEC INC 411100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R