BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 2132242 · Received June 14, 2011

    Report

    Report Number
    2243969-2011-00016
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: A VERY ILL PT WAS ADMITTED TO ITU ON (B)(6), 2011 AND HAD THE KIT IN SITU TO CONTAIN DIARRHEA OF UNK ETIOLOGY UNTIL THE (B)(6). THE KIT WAS DISCONTINUED ON THE DISCOVERY OF NECROTIC TISSUE WHICH SUBSEQUENTLY WAS DESCRIBED AS A GRADE IV PRESSURE ULCER 1CM X2CM X4CM DEEP RUNNING FROM THE PT'S SKIN SURFACE AND INTO THE ANUS/ANAL CANAL ON THE (B)(6). THE PT WAS VERY ILL ON ADMISSION AND DIED ON THE (B)(6) 2011. THIS CASE HAS BEEN REVIEWED AND DEEMED A SERIOUS ADVERSE EVENT DUE TO THE FATAL OUTCOME OF THE PT. INFORMATION KNOWN THUS FAR, VIA E-MAIL, IS THAT THE CAUSE OF DEATH WAS LISTED AS VCA AND HTN (CEREBROVASCULAR ACCIDENT AND HYPERTENSION) WITH PANHYPOPITUITARISM AS THE OTHER SIGNIFICANT CONDITION CONTRIBUTING TO DEATH. PT ADMITTED ON (B)(6). FMS WAS INSERTED DUE TO LIQUID STOOL . A NECROTIC ANAL/RECTAL ULCER WAS DISCOVERED ON (B)(6), AND THERE IS CONFLICTING INFORMATION AS TO WHETHER THE DEVICE WAS DISCONTINUED AT THAT TIME. THE PT EXPIRED ON (B)(6). REPORT STATES THAT THERE WAS NO MENTION OF THE BOWEL MANAGEMENT SYSTEM BEING RELATED TO THE PT'S DEATH, HOWEVER, AN OFFICIAL EVALUATION HAS BEEN REQUESTED AND THIS CASE WILL BE UPDATED IF IT IS REC'D. THERE WAS NO MEDICAL PROCEDURE PERFORMED TO TREAT THE NECROTIC TISSUE AND PRESSURE ULCER, AND NO POST MORTEM WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-SEAL SIGNAL FMS FECAL MANAGEMENT SYSTEM KNT CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death