BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1013671 · Received March 14, 2008

    Report

    Report Number
    2523003-2008-00009
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K033562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    BALLOON WAS LEAKING WHILE IN THE PATIENT; DOCTOR THINKS THAT THE BALLOON IS DEFLATING UNDER THE GASTRIC JUICES, TUBE HAD TO BE REMOVED BECAUSE THE LEAK WAS SO BAD. THE DOCTOR THINKS THE SILICONE IS NOT THICK ENOUGH AND DEFLATES IN THE STOMACH, THEN REINFLATES AFTER IT IS EXPOSED TO AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention