BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 2921570 · Received January 16, 2013

    Report

    Report Number
    2243969-2013-00003
    Event Type
    Death
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 26, 2012
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THE AE; RECTAL ULCERATION IS DEEMED SERIOUS AND POSSIBLY RELATED TO THE USE OF THE FECAL COLLECTION DEVICE. THE DEATH OF THE PATIENT IS NOT BELIEVED TO BE RELATED TO THE USE OF THE DEVICE BUT A STATEMENT DECLARING THE CAUSE OF DEATH AND ITS RELATEDNESS OR OTHERWISE TO THE DEVICE USE HAS BEEN SOUGHT BY US FROM THE USER FACILITY. REPORTED TO FDA ON (B)(4)2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: REPORTING ON (B)(6) 2012 PATIENT ADMITTED WITH COMPLAINT OF ABDOMINAL PAIN NAUSEA AND VOMITING. FMS INSERTED FOR MEDICATION ADMINISTRATION PURPOSES. FMS REMOVED ON (B)(6) 2012 DUE TO COMPLAINT OF PAIN AND UNABLE TO EXPEL STOOL. UPON EXAMINATION BY PHYSICIAN AN ULCERATION OF RECTAL AREA WAS NOTED. A TOTAL OF 405CC HAD BEEN ADMINISTERED INTO BALLOON OF FMS BY STAFF NURSE. THE PATIENT WAS ADMITTED INTO HOSPITAL FOR ABDOMINAL PAIN, NAUSEA AND VOMITING. HER ACTIVE CO MORBIDITIES INCLUDED: SMALL BOWEL OBSTRUCTION, COLITIS, CIRRHOSIS, THROMBOCYTOPENIA, INSULIN DEPENDENT DIABETES, HYPERTENSION, ASCITES AND HYPERAMMONEMIA. THE PATIENT WAS NOT ON ANY ANTI-COAGULANTS. THE FLEXI-SEAL FMS DEVICE WAS INSERTED (B)(6) 2012 FOR MEDICATION ADMINISTRATION AND WAS REMOVED TWO DAYS LATER ON (B)(6) 2012 WHEN PATIENT WAS IN PAIN AND UNABLE TO PASS STOOL. THE BALLOON WAS INITIALLY INFLATED WITH 45CC OF FLUID AND 360CC MORE FLUID WAS LATER ADDED. ON REMOVAL OF THE DEVICE, RECTAL ULCER WAS DISCOVERED DESCRIBED AS ¿LARGE ULCERATION WITHIN THE RECTUM¿ DIGITAL EXAMINATION AND FLEXIBLE SIGMOIDOSCOPY WERE CARRIED OUT. PATIENT WAS TREATED WITH RECTAL SUCRALFATE (CARAFATE) A GASTROINTESTINAL ULCER MEDICATION. NO RECTAL/ANAL BLEEDING WAS REPORTED IN THIS CASE. THE PATIENT IS SAID TO HAVE ¿PASSED AWAY¿ FROM MANY OTHER COMPLICATIONS BUT THE EXACT DATE/TIME AND CAUSE OF DEATH HAS NOT BEEN REPORTED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23656 FLEXI-SEAL SIGNAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. NA UNK

    Patients

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