BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONVATEC FLEXISEAL

    MDR report key: 1252367 · Received November 25, 2008

    Report

    Report Number
    MW5009112
    Event Type
    Other
    Date Received
    November 25, 2008
    Date of Event
    May 9, 2008
    Report Date
    November 25, 2008
    Manufacturer
    CONVATEC DIVISION OF ER SQUIBB & SONS, LLC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A FLEXI SEAL FECAL MANAGEMENT SYSTEM THAT LED TO RECTAL BLEEDING REQUIRING VASOPRESSORS, BLOOD TRANSFUSIONS, FFP AND DDAVP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVATEC FLEXISEAL FLEXISEAL FECAL MANAGEMENT SYSTEM KNT CONVATEC DIVISION OF ER SQUIBB & SONS, LLC SL2037

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other