BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCT SPECIALIZED TRACH

    MDR report key: 334318 · Received May 21, 2001

    Report

    Report Number
    2029387-2001-00054
    Event Type
    Malfunction
    Date Received
    May 21, 2001
    Report Date
    May 18, 2001
    Manufacturer
    MALLINCKRODT, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 90 DEGREE ANGLE ON CANNULA OF CUSTOM TRACH IS RELAXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23695 SCT SPECIALIZED TRACH TRACHEOSTOMY TUBE BTO MALLINCKRODT, INC. NA M16772000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN