BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHIL, TRACHEOSTOMY

    MDR report key: 3852930 · Received May 23, 2014

    Report

    Report Number
    2936999-2014-00445
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    May 10, 2013
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADD'L INFO AVAILABLE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A LITIGATION COMPLAINT AND RELATED DOCUMENT ON (B)(4) 2014. COVIDIEN CLINICAL TEAM HAS REVIEWED THE DOCUMENTS AND SUMMARIZED THE REPORTED CIRCUMSTANCES OF THIS EVENT AS FOLLOWS: ON (B)(6) 2012, A PT UNDERWENT A TRACHEOSTOMY. IT IS THEN ALLEGED THAT DURING THE PROCEDURE, THE SHILEY TRACHEOSTOMY TUBE (MODEL UNK) WAS DEFECTIVE AND NEEDED TO BE REPLACED. THE PT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2013. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307766 SHIL, TRACHEOSTOMY NONE JOH COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R