BEUDAMED
    FDA Adverse Event Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1032505 · Received April 17, 2008

    Report

    Report Number
    2523003-2008-00039
    Date Received
    April 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K033562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BALLOON DEFLATED WHILE IN THE PT, CAUSING LEAKAGE AROUND THE SITE, AND SUBSEQUENT REMOVAL OF THE G-TUBE.

    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