BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY CUFFLESS TRACHEOSTOMY TUBE

    MDR report key: 131325 · Received November 12, 1997

    Report

    Report Number
    2029387-1997-00160
    Event Type
    Injury
    Date Received
    November 12, 1997
    Date of Event
    August 26, 1997
    Report Date
    September 12, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE 8CFS DEVICE WAS RETURNED TO THE MANUFACTURER FOR DECONTAMINATION, ANALYSIS AND INVESTIGATION ON 04/02/1998. DEVICE EVALUATION RESULTS RECORDED ON SECTION H OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY CUFFLESS TRACHEOSTOMY TUBE Implant TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 8CFS M61374000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 2. SWIVEL FLEX ADAPTOR (MFR. MODEL TYPE UNKNOWN)| 1. COMPANION 26 VENTILATOR