BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T

    MDR report key: 127756 · Received October 20, 1997

    Report

    Report Number
    2029387-1997-00145
    Event Type
    Malfunction
    Date Received
    October 20, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 11, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER' DEVICE EVALUATION RESULTS ARE RECORDED ON SECTION H. OF THIS FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6DCT M67230000 & UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR PLV 100 VENTILATOR, SWIVEL ADAPTORS (MFR. MODEL| TYPE UNKNOWN)