BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXI-TIP WITH SILICONE CUFF

    MDR report key: 542482 · Received September 2, 2004

    Report

    Report Number
    2647856-2004-00007
    Event Type
    Death
    Date Received
    September 2, 2004
    Date of Event
    August 3, 2004
    Report Date
    August 4, 2004
    Manufacturer
    E-Z-EM CARIBE
    Product Code
    FGD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BARIUM ENEMA WAS PERFORMED ON A PT. THE EXAM STARTED AND WAS COMPLETED WITHOUT ANY INDICATION OF AN ADVERSE REACTION (NO PT COMPLAINTS NOR SUSPECT FINDINGS ON THE X-RAY IMAGES). THE PT WAS SENT HOME IN THE USUAL WAY. IN THE EVENING THE PT FELT INCREASING ABDOMINAL PAIN AND WENT TO A HOSP NEARBY. THEY WERE TREATED REGARDING THE SYMPTOMS OF A PERITONITIS BUT THE NEXT MORNING THEY WERE SENT TO THE CT WHERE AN EXTRALUMINAL (SMALL) DEPOSIT OF CONTRAST MEDIA WAS FOUND. ALTHOUGH A SURGICAL INTERVENTION WAS INITIATED IMMEDIATELY THE PT DIED. THE CORPSE WAS CONVEYED TO THE PATHOLOGY DEPARTMENT FOR AN AUTOPSY. THE INITIAL AUTOPSY RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-TIP WITH SILICONE CUFF RECTAL CATHETER W/RETENTION BALLOON FGD E-Z-EM CARIBE NA 2273865N

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death 849NEU-ONE SHOT INFLATOR (MFG BY E-Z-EM, INC.)