BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD MINNESOTA FOUR LUMEN ESOPHAGOGASTRIC TUBE

    MDR report key: 464426 · Received June 5, 2003

    Report

    Report Number
    1018233-2003-00022
    Event Type
    Death
    Date Received
    June 5, 2003
    Date of Event
    May 4, 2003
    Report Date
    June 5, 2003
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BALLOON ON A PRODUCT BEING USED FOR EMERGENCY TREATMENT OF BLEEDING ESOPHAGEAL VARICES BURST SHORTLY AFTER TRACTION WAS APPLIED. THE PRODUCT WAS REMOVED AND REPLACED WITH NO COMPLICATIONS REPORTED. THE PATIENT LATER DIED AS A RESULT OF A PERFORATED ESOPHAGUS. WHILE THE DOCTOR AND NURSING STAFF ARE VERY CONCERNED AT THE BURST, THEY BELIEVE THAT THE PERFORATION COULD HAVE OCCURRED AS A RESULT OF OTHER TREATMENT THE PATIENT WAS RECEIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MINNESOTA FOUR LUMEN ESOPHAGOGASTRIC TUBE ESOPHAGOGASTRIC TAMPONADE TUBE KNT C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death