BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECUT LO-PRO

    MDR report key: 15886 · Received July 21, 1994

    Report

    Report Number
    15886
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    May 20, 1994
    Report Date
    May 25, 1994
    Manufacturer
    MALLINCKRODT CRITICAL CARE
    Product Code
    BSK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE OR A CARLENS TUBE WAS INITIALLY INSERTED AND #9.0 ET TUBE INSERTED WHEN CARLENS REMOVED. ANESTHESIA NOTED "VERY EDEMATOUS - NO RECOGNIZABLE STRUCTURES. THROAT AND NECK ALSO VERY EDEMATOUS". PATIENT RECEIVED TO SICU (5/19/94) HEMOSTAT IN PLACE ON CUFF BALLOON TUBING WHICH MAINTAINED CUFF LEAK. WORSE LEAK NOTED AT 1145, 5/20/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECUT LO-PRO Implant TRACHEAL TUBE BSK MALLINCKRODT CRITICAL CARE 9.0.MM. I.D. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention HUMDIFICATION SYSTEM| VENTILATOR ADULT STAR CONCHA