BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY #8 DIC

    MDR report key: 273529 · Received April 12, 2000

    Report

    Report Number
    2029387-2000-00046
    Event Type
    Death
    Date Received
    April 12, 2000
    Date of Event
    March 20, 2000
    Report Date
    April 12, 2000
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPOSABLE INNER CANNULA (DIC) BECAME DETACHED WHILE IN USE. NOTE: ACTUAL PRODUCT DESCRIPTION NOT AVAILABLE AT THIS POINT. REPORTED INFO ONLY INDICATES THAT IT'S SIZE 8 DISPOSABLE INNER CANNULA. AS OF THE DATE ON THIS REPORT, THE INVOLVED DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY #8 DIC TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8DIC M99133000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death VENTILATOR MODEL - AEQUITRON LP10 VENT.