BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL CONTROL FMS

    MDR report key: 3674899 · Received February 28, 2014

    Report

    Report Number
    2243969-2014-00049
    Event Type
    Death
    Date Received
    February 28, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 24, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ULCERATION AND SEPSIS/DEATH. CLINICIAN REPORTED UNKNOWN CAUSE OF SEPSIS AND UNKNOWN IF FLEXI-SEAL CONTROL DEVICE IS RELATED TO ULCERATION AND SEPSIS/DEATH. COMPLAINANT IS UNABLE TO PROVIDE DEVICE LOT NUMBER, IN ADDITION REQUEST HAS BEEN SENT TO COMPLAINANT IN REGARDS TO WHETHER BLOOD TRANSFUSION WAS GIVEN TO PT DURING HOSPITALIZATION AS WELL DETAILS ON PT'S HEIGHT AND WEIGHT. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES. 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. 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. PT ON HOME ANTICOAGULANT THERAPY PRIOR AND UPON ADMISSION TO HOSPITAL. IT IS REPORTED THAT THIS WAS DISCONTINUED ON (B)(6) 2014 UPON ADMISSION.

    Description of Event or Problem · 1

    INFO RECEIVED VIA FLEXISEAL QUESTIONNAIRE IS INDICATED AS FOLLOWS: TERRITORY MANAGER RECEIVED INFO FROM FACILITY'S ICU MANAGER WHO REPORTED OF A (B)(6) MALE ADMITTED FROM THE EMERGENCY DEPARTMENT PRESENTING WITH UPPER GI BLEED ON (B)(6) 2014. ON (B)(6) 2014 AN UPPER GI SCOPE PERFORMED THROUGH TO THE DUODENUM SHOWING MUCOSA FREE OF ULCERATION. IT IS REPORTED THAT THE FLEXI-SEAL CONTROL DEVICE WAS INSERTED ON (B)(6) 2014 RELATED TO LOOSE STOOL AND TO KEEP FEMORAL LINE CLEAN AND SHOWED NO SIGNS OF C DIFFICILLE. IT IS ALSO REPORTED THAT THE DEVICE WAS REMOVED RELATED TO DISCOVERY OF MAROON COLORED STOOL ON (B)(6) 2014 AND RECTOSIGMOIDOSCOPY PERFORMED ON (B)(6) 2014 RELATED TO DISCOVERY OF 10CM RECTAL MUCOSA ULCERATION WITH REMOVAL OF FLEXI-SEAL CONTROL DEVICE ON DAY 16 ((B)(6) 2014). ON (B)(6) 2014 A DIVERTING COLOSTOMY WAS PERFORMED RELATED TO THE ULCERATION OF RECTAL MUCOSA BEING DISCOVERED ON THE FLEXSIGMOIDOSCOPY. IN CONCLUSION, PT EXPIRED ON (B)(6) 2014 RELATED TO SEPSIS. IT IS REPORTED THAT DEVICE WAS IN PLACE FOR FOURTEEN (14) DAYS BEFORE THE PROBLEM WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125044 FLEXI-SEAL CONTROL FMS GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC, INC. 411107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| L| O| R