BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1233857 · Received November 13, 2008

    Report

    Report Number
    2243969-2008-00011
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS...A MALE ADMITTED IN 2008 WITH DEHYDRATION; UTI; DIARRHEA AND A WBC COUNT OF 28;000. PATIENT'S CHIEF COMPLAINT WAS WEAKNESS. ADMITTING NURSE NOTED HIS ABDOMEN WAS DISTENDED AND PATIENT COMPLAINED OF ABDOMEN CRAMPING. PATIENT HAS BEEN RECEIVING TREATMENT FOR C-DIFF FOR THE PAST TWO YEARS. FMS PLACED DUE TO DIARRHEA. ON THE NEX DAY, PATIENT HAD AN ABDOMEN X-RAY WHICH SHOWED FREE AIR. ON THE FOLLOWING DAY, PATIENT HAD A SURGICAL CONSULT AND KUB WHICH SHOWED GAS SUGGESTING POSSIBLE MILD ILEUS. ON THE NEXT DAY, PATIENT WENT TO SURGERY FOR PROSTATECTOMY WITH BIOPSY OF RECTAL MUCOSA; EXPLORATORY LAP WITH DIVERTING END SIGMOID COLOSTOMY; JP DRAIN PLACEMENT; DEBRIDEMENT OF POST ANAL PERIRECTAL TISSUE AND DRAIN PLACEMENT X 2. SURGICAL SUMMARY STATES THERE APPEARED TO BE A PERFORATION JUST ABOVE SPHINCTER COMPLEX AND 1 CM TEAR AT RECTUM AT ANAL VERGE WITH AN OPENING IN THE SKIN. SURGICEL NOTE ALSO STATES ISCHEMIC NECROTIC TISSUE LEFT AND RIGHT ISCHIORECTAL SPACES AND POSTERIOR ANAL SPACE. PATIENT IS CURRENTLY RECEIVING TREATMENT ON THE MEDICAL SURGICAL FLOOR. TREATMENT INCLUDES WOUND CARE TO PERIRECTAL WOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention