BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 GASTRO-ENTERIC TUBE

    MDR report key: 19458 · Received February 6, 1995

    Report

    Report Number
    MW1005040
    Event Type
    Malfunction
    Date Received
    February 6, 1995
    Date of Event
    December 10, 1994
    Report Date
    December 21, 1994
    Manufacturer
    MEDICAL INNOVATIONS CORP.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SMALL BOWEL ENTEROSCOPY, THE GASTRO-ENTERIC TUBE BALLOON TRAPPED THE SCOPE IN THE SMALL BOWEL AND HAD TO BE REMOVED UNDER FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20 GASTRO-ENTERIC TUBE KNT MEDICAL INNOVATIONS CORP. 210-20

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other