BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3337693 · Received September 4, 2013

    Report

    Report Number
    2936999-2013-00647
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 5, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS ASSOCIATED TO THIS REPORT. IF THE SAMPLE BECOMES AVAILABLE THE RESULTS OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THAT THE TUBE PRESENTED A OCCLUSION DURING PATIENT USE AND REPORTED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438181 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention