BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PONSKY NON-BALLOON G-TUBE

    MDR report key: 237342 · Received July 23, 1999

    Report

    Report Number
    1223688-1999-00018
    Event Type
    Malfunction
    Date Received
    July 23, 1999
    Date of Event
    April 1, 1999
    Report Date
    May 14, 1999
    Manufacturer
    BIPD DIV., CR BARD
    Product Code
    KNT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DOME SEPARATED FROM TUBE AND WAITING TO PASS THRU PT. TUBE HAS BEEN IN PLACE SINCE 07/1998. THIS MAY HAVE BEEN CAUSED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PONSKY NON-BALLOON G-TUBE Implant FEEDING TUBE KNT BIPD DIV., CR BARD 61 000630 43KIA005

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization