BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-SEAL FMS

    MDR report key: 1639383 · Received March 18, 2010

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    2243969-2010-00012
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    April 3, 2009
    Report Date
    February 22, 2010
    Manufacturer
    CONVATEC
    Product Code
    MIP
    PMA / PMN Number
    K032734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    REPORTED FROM PUBLISHED ARTICLE: "RECTAL TRAUMA AND ASSOCIATED HEMORRHAGE WITH THE USE OF THE CONVATEC FLEXI-SEAL FECAL MANAGEMENT SYSTEM: REPORT OF 3 CASES". A (B) (6), RESIDENT, OF AN EXTENDED CARE FACILITY (ECF) PRESENTED WITH AN ACUTE LOWER GI BLEED. ONSET OF BLEEDING OCCURRED AFTER AN FMS WAS TRAUMATICALLY PULLED FROM HER RECTUM DURING TRANSFER FROM WHEELCHAIR TO HER BED. EXCEPT FOR ASPIRIN, THE PT WAS RECEIVING NO OTHER ANTICOAGULATIVE. COLONOSCOPY WAS PERFORMED AND 2-CM RECTAL TEAR WAS NOTED APPROX 4 CM PROXIMAL TO THE DENTATE LINE. CLOT WAS ADHERENT TO THE LACERATION, SO NO INTERVENTION WAS PERFORMED. SHE HAD NO FURTHER BLEEDING DURING THE NEXT DAYS AND WAS DISCHARGED. ONE WEEK LATER, THE PT RETURNED WITH HYPOTENSION AND BRIGHT RED BLOOD PER RECTUM. PULSATILE BLEEDING WAS OBSERVED ORIGINATING FROM THE PRIOR LACERATION (FIG.1) TRANSANAL SUTURE LIGATION WAS PERFORMED, WHICH ACHIEVED HEMOSTASIS. AN INTERVAL EXAMINATION REVEALED A WELL-HEALED SITE, AND THE PT HAS HAD NO FURTHER COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R