BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMT BRIDLE

    MDR report key: 10384290 · Received August 10, 2020

    Report

    Report Number
    10384290
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 6, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMT BRIDLE WAS IN PLACE TO SECURE NASOGASTRIC TUBE. PATIENT GRABBED DEVICE AND YANKED IT OUT RIPPING OUT HER SEPTUM CAUSING MASSIVE BLEEDING AND REQUIRING IMMEDIATE SURGICAL INTERVENTION AT BESIDE. BASED ON MY RESEARCH WITH THE VENDOR AND OTHER INFORMATION ALREADY GATHERED THIS HAS NEVER HAPPENED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852425 AMT BRIDLE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Life Threatening| R