BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GASTROSTOMY PLACEMENT KIT

    MDR report key: 36122 · Received August 2, 1996

    Report

    Report Number
    MW4001446
    Event Type
    Injury
    Date Received
    August 2, 1996
    Date of Event
    April 17, 1996
    Report Date
    April 22, 1996
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLUE INTRODUCER DETACHED FROM PEG TUBE DURING INSERTION WITH NORMAL TRACTION. GRASPED END OF PEG (LEFT IN ABD.) THE HEMOSTAT PER PHYSICIAN AND PULLED TO CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GASTROSTOMY PLACEMENT KIT GASTROSTOMY PLACEMENT KIT KNT APPLIED MEDICAL TECHNOLOGY, INC. * 9640503

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention