BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1022017 · Received March 31, 2008

    Report

    Report Number
    2523003-2008-00017
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 4, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS REC'D THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 180 DAYS. THE DOME PORTION WAS REMOVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C.R. BARD, INC. (BASD) HURE2881

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention