BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1914946 · Received November 29, 2010

    Report

    Report Number
    2243969-2010-00055
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(4) 2010.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: TWO END USERS HAD FMS PLACED AND IT WAS REPORTED THEY WERE TAKEN TO SURGERY AND REQUIRED BLOOD TRANSFUSIONS. SECOND CASE REPORTED UNDER MEDWATCH FORM 2243969-2010-00056.

    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