BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-SEAL SIGNAL

    MDR report key: 5406503 · Received February 3, 2016

    Report

    Report Number
    5406503
    Event Type
    Death
    Date Received
    February 3, 2016
    Date of Event
    January 30, 2015
    Report Date
    December 18, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRITICALLY ILL PATIENT WITH ACUTE NECROTIZING PANCREATITIS AND LONG-STANDING RECTAL TUBE DEVELOPED ACUTE ONSET GI HEMORRHAGE WITH HYPOTENSION. NO ACTIVE BLEEDING SEEN ON ANGIOGRAPHY, UNDERWENT EGD AND COLONOSCOPY IN ANGIOGRAPHY SUITE, WHICH SHOWED RECTAL ULCERATION WITH PROFUSE BLEEDING AT APPROXIMATELY 3CM FROM THE ANAL VERGE. COULD NOT BE CONTROLLED ENDOSCOPICALLY. HE REMAINED HEMODYNAMICALLY UNSTABLE WITH ONGOING TRANSFUSION REQUIREMENT. AFTER DISCUSSING FURTHER INVASIVE TREATMENT PLANS, FAMILY TRANSITIONED TO COMFORT MEASURES. ONLY PLAUSIBLE SOURCE OF BLEEDING IS ULCERATION FROM RECTAL TUBE. APPROXIMATELY 4 DAYS LATER, THE SURGEON EXPRESSED CONCERN REGARDING THE TUBE AND RECOMMENDED REPORTING TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65475 FLEXI-SEAL SIGNAL TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CONVATEC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death CARDIAC DRUGS