BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHIELY, DISPOSABLE SIZE 6, EXACT PRODUCT TYPE UNKNOWN

    MDR report key: 383113 · Received March 19, 2002

    Report

    Report Number
    2029387-2002-00028
    Event Type
    Death
    Date Received
    March 19, 2002
    Date of Event
    March 2, 2002
    Report Date
    March 18, 2002
    Manufacturer
    MALLINCKRODT INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE "DIC" BECAME DISCONNECTED FROM THE OUTER CANNULA, BUT REMAINED ATTACHED TO THE VENTILAR, AS A RESULT THE PT EXPIRED. LIMITED INFO PROVIDED. EXACT PRODUCT DESCRIPTION UNKNOWN. SIZE 6 DIC, CUFFED DEVICE, LOT #UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHIELY, DISPOSABLE SIZE 6, EXACT PRODUCT TYPE UNKNOWN TRACHEOSTOMY TUBE BTO MALLINCKRODT INC. SHILEY, SIZE 6 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death LP10 VENTILATOR.