BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE

    MDR report key: 127786 · Received October 20, 1997

    Report

    Report Number
    2029387-1997-00147
    Event Type
    Malfunction
    Date Received
    October 20, 1997
    Date of Event
    July 24, 1997
    Report Date
    August 15, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ONE (1) 6 SCT DEVICE WAS RETURNED ON 9/15/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SINGLE CANNULA CUFFED TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE JOH MALLINCKRODT MEDICAL, INC. 6SCT M70512000 & UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * LIFE CARE PLV 100, CASCADE HUMIDIFIER