BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2890564 · Received December 20, 2012

    Report

    Report Number
    2936999-2012-00694
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE TUBE DEVELOPED A CUFF LEAK DURING PT USE. CUSTOMER REPORTED THAT NON ROUTINE EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention