BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT LO-PRO TRACHEAL TUBE

    MDR report key: 1637101 · Received March 18, 2010

    Report

    Report Number
    2936999-2010-00398
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 18, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    PMA / PMN Number
    K802505
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT A CUFF "BLEW" ON THE ENDOTRACHEAL TUBE AFTER IT WAS IN USE FOR 24 HOURS. NON-ROUTINE REPLACEMENT OF THE TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LO-PRO TRACHEAL TUBE ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention