BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASIVE GASTROSTOMY TUBE 20FR

    MDR report key: 34632 · Received July 16, 1996

    Report

    Report Number
    34632
    Event Type
    Injury
    Date Received
    July 16, 1996
    Date of Event
    July 3, 1996
    Report Date
    July 16, 1996
    Manufacturer
    AMERICAN MEDICAL TECHNOLGIES BOSTON SCIENTIFIC CORP. EENDOSCOPY DIV.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 5/29/96, DR PLACED A GASTROSTOMY TUBE INTO THE PT. ON 7/3/96 DR PERFORMED AN ESOPHAGOGASTRODUODENOSCOPY AND FOUND THE GASTROSTOMY TUBE BULB LODGED IN THE WALL OF THE STOMACH. THE MIGRATED GASTROSTOMY TUBE WAS REMOVED AND A 20 FRENCH GASTROSTOMY TUBE WAS INTRODUCED AND LEFT IN THE APPROPRIATE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE GASTROSTOMY TUBE 20FR Implant GASTROSTOMY TUBE 20FR KNT AMERICAN MEDICAL TECHNOLGIES BOSTON SCIENTIFIC CORP. EENDOSCOPY DIV. 6420 9646005

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R