BEUDAMED
    FDA Adverse Event Death Summary report: N

    PONSKY REPL. TUBE-20

    MDR report key: 677163 · Received February 14, 2006

    Report

    Report Number
    1720496-2006-00059
    Event Type
    Death
    Date Received
    February 14, 2006
    Date of Event
    September 16, 2005
    Report Date
    January 18, 2006
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THE PONSKY REPLACEMENT DONE IN THE CLINIC BY A TRAINED PEG NURSE. SUBSEQUENTLY, PT WAS ADMITTED TO HOSPITAL IN 2005 BECAUSE OF PAIN WHILE FEEDING VIA PONSKY REPLACEMENT TUBE. AN OGD WAS DONE THE NEXT DAY AND THE PONSKY INTERNAL BUMPER WAS NOT SEEN IN THE STOCMACH. THE PEG WAS THEREFORE REMOVED. CT SCAN WAS DONE AND SHOWED SOME FLUIDS IN THE PERITONEUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONSKY REPL. TUBE-20 REPLACEMENT G-TUBES KNT C.R. BARD, INC. (BASD) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death