BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY REPL TUBE -20

    MDR report key: 679528 · Received February 14, 2006

    Report

    Report Number
    1720496-2006-00058
    Event Type
    Malfunction
    Date Received
    February 14, 2006
    Date of Event
    November 1, 2005
    Report Date
    January 18, 2006
    Manufacturer
    C.R. BARD, INC.(BASD)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PONSKY REPLACEMENT DONE BY A REGISTRAR. PATIENT DEVELOPED PAIN AFTER THE PEG TUBE WAS FLUSHED WITH WATER AND ALSO VOMITED. AN OGD WAS DONE ON THE DAY AND THE INTERNAL BUMPER WAS NOT IN THE STOMACH.

    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 70 YR Required Intervention