BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1081049 · Received July 18, 2008

    Report

    Report Number
    3006260740-2008-00048
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 1, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 147 DAYS. THE DOME PORTION WAS REMOVED THROUGH THE STOMA SITE.

    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