BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INITIAL PLACEMENT GASTROSTOMY KIT

    MDR report key: 35883 · Received August 13, 1996

    Report

    Report Number
    1527288-1996-00014
    Event Type
    Injury
    Date Received
    August 13, 1996
    Date of Event
    July 26, 1996
    Report Date
    August 13, 1996
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS PLACED ON 7/19/96 IN A CVA (CEREBRAL ACCIDENT VICTIM) PT. ON 7/26/96, THE PT EXPERIENCED GI BLEEDING. AN ENDOSCOPY WAS PERFORMED AND IT WAS NOTED THE INTERNAL BOLSTER HAD ERODED INTO THE ABDOMINAL WALL AND HAD MADE AN ULCERATION. A BLEEDING ULCERATED AREA AT THE SITE OF EROSION WAS NOTED. THE FEEDING TUBE WAS REMOVED ENDOSCOPICALLY. A G-TUBE WAS PLACED AND THE BALLOON WAS USED TO TAMPONADE THE BLEED. THE PT'S CONDITION AFTERWARDS WAS REPORTEDLY GOOD. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. AGE AT TIME OF EVENT LISTED AS 65-68.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INITIAL PLACEMENT GASTROSTOMY KIT PERCUTANEOUS FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention