BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T

    MDR report key: 220177 · Received April 21, 1999

    Report

    Report Number
    2029387-1998-00093
    Event Type
    Malfunction
    Date Received
    April 21, 1999
    Date of Event
    July 21, 1998
    Report Date
    August 16, 1998
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE 6 DCT DEVICE WAS REPORTEDLY UNAVAILABLE TO BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION. HOWEVER, ON 10/9/98 THE 6 DCT DEVICE WAS RETURNED TO THE MFR FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION. THE MFR DEVICE EVALUATION RESULTS ARE RECORDED ON SECTION H OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE CANNULA LOW PRESSURE CUFFED TRACHEOSTOMY T Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 DCT M77942000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR