BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEA FMS

    MDR report key: 1931545 · Received December 10, 2010

    Report

    Report Number
    2243969-2010-00063
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CONVATEC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: WE REPORT THE CASE OF (B)(6) OLD MAN WHO DEVELOPED MASSIVE RECTAL BLEEDING ASSOCIATED WITH HE USE OF A FECAL COLLECTING DEVICE: THE FLEXI-SEAL FECAL MANAGEMENT SYSTEM. A COLONOSCOPY SHOWED AN ACUTE LACERATION OF THE ANTERIOR RECTAL WALL MUCOSA, 6 CM FROM THE ANAL VERGE, WITH ACTIVE BLEEDING. THE TEAR WAS MOST LIKELY THE RESULT OF AN ACUTE EVENT, SUCH AS SUDDEN MOVEMENT OF THE DEVICE WITHIN THE RECTUM OR TRAUMA SUSTAINED DURING INSERTION. MASSIVE TRANSFUSION WAS REQUIRED, AND SURGICAL ENDOSCOPIC TREATMENT WAS NECESSARY TO ENSURE HEMOSTASIS. THIS IS, TO OUR KNOWLEDGE, THE FIRST SUCH CASE TO BE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention