BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 4092329 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00775
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 6, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE OF A 7SCT TRACHEOSTOMY TUBE, IT WAS OBSERVED THAT THE CONNECTOR OF THE DEVICE WAS NOT TAPERED TO ALLOW PLACING THE SPEAKING VALVE. THE UNIT WAS REMOVED AND A NEW TAPERED ONE WAS PLACED IN THE PATIENT, WHO TOLERATED THE EXCHANGE WITHOUT INCIDENTS. THE FAULTY DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500212 SHILEY TRACHEOSTOMY TUBE JOH COVIDIEN 14F0433JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention