BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1436241 · Received June 17, 2009

    Report

    Report Number
    2243969-2009-00010
    Event Type
    Injury
    Date Received
    June 17, 2009
    Date of Event
    May 13, 2009
    Report Date
    May 19, 2009
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS... INFORMATION SUPPLIED FROM MEDWATCH: PT HAD A FLEXISEAL PLACED IN 2009. TO LTAC AT APPROX 2 WEEKS LATER. READMITTED TO ICU ABOUT 2 DAYS LATER FOR LOW GRADE GI BLEED. PT ON HEPARIN GTT AND BALLOON HAD 60ML IN RESERVOIR. DIAGNOSIS: DIARRHEA. EVENT ABATED AFTER USE: YES. INSERTED IN 2009. D/C/ AT APPROX 21 DAYS LATER.

    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 Required Intervention