BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCT SPECIALIZED TRACH

    MDR report key: 347811 · Received August 16, 2001

    Report

    Report Number
    2029387-2001-00072
    Event Type
    Malfunction
    Date Received
    August 16, 2001
    Report Date
    August 14, 2001
    Manufacturer
    MALLINCKRODT, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, PT HAS TO REMOVE TRACH TUBE FOR CLEANING ABOUT EVERY 3 DAYS. AS A RESULT, TUBES ONLY LAST ABOUT 20-21 DAYS. TUBES GET VERY SOFT AND DON'T ALLOW PT TO BREATHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37614 SCT SPECIALIZED TRACH SPECIALIZED TRACHEOSTOMY TUBE BTO MALLINCKRODT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN