BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 6168546 · Received December 12, 2016

    Report

    Report Number
    2936999-2016-01066
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    November 29, 2016
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TRACHEOSTOMY TUBE IS AN OVAL SHAPE, BUT SHOULD BE A ROUND SHAPE. THERE WAS NO PATIENT INVOLVEMENT OR ANY REQUIRED INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818859 SHILEY SCT SPECIALIZED TRACH BTO COVIDIEN MSCT 16J0338JZX

    Patients

    Seq Age Sex Outcome Treatment
    1