BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL SIGNAL FMS

    MDR report key: 1931597 · Received December 10, 2010

    Report

    Report Number
    2243969-2010-00060
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: A PT EXPERIENCED RECTAL BLEEDING AFTER FLEXISEAL FMS SIGNAL WAS PLACED. PT WAS IN MICU FOR LIVER PROBLEMS. MD STATED BALLOON WAS INFLATED APPROPRIATELY.

    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 Required Intervention