BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE

    MDR report key: 33503 · Received June 5, 1996

    Report

    Report Number
    33503
    Event Type
    Death
    Date Received
    June 5, 1996
    Date of Event
    May 31, 1996
    Report Date
    June 5, 1996
    Manufacturer
    BARD INTERVENTIONAL PRODUCTS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A 12-YR-OLD FEMALE THAT PRESENTED ON 4/29/96 TO OUTPT GI LAB FOR REPLACEMENT OF G-BUTTON SECONDARY TO LEAKING OF CURRENT G-BUTTON. G-BUTTON REPLACED BY PEDIATRIC GASTROENTEROLOGIST WITHOUT DIFFICULTY. PT RE-PRESENTED BACK TO ER LATER THAT EVENING IN ACUTE DISTRESS. PT ARRESTED. RESUSCITATIVE EFFORTS NOT SUCCESSFUL AND PT EXPIRED. AUTOPSY RESULTS ON 5/31/96 REVEALED PERFORATION OF STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BUTTON REPLACEMENT GASTROSTOMY DEVICE Implant GASTROSTOMY BUTTON KNT BARD INTERVENTIONAL PRODUCTS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death