BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3763224 · Received April 9, 2014

    Report

    Report Number
    2243969-2014-00179
    Event Type
    Death
    Date Received
    April 9, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS BEING REPORTED AS A DEATH; HOWEVER, IT IS NOT KNOWN WHETHER THE DEVICE IS RELATED TO THE CAUSE OF DEATH. NO OTHER DETAILS KNOWN AT THIS TIME. THE LOT NUMBER IS NOT AVAILABLE. COMPLAINANT HAS BEEN CONTACTED VIA PHONE AND PAGER, AND EMAIL INFO HAS REQUESTED IN ORDER TO ASCERTAIN ADDITIONAL PT/EVENT INFO. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MFG SITE. BOTH POTENTIAL MFG SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVAL 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 UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT DIED WHILE USING FMS KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212957 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE AND ACCESSORIES, 78KNT KNT CONVATEC, INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R