BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2930339 · Received January 22, 2013

    Report

    Report Number
    2936999-2013-00049
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 23, 2012
    Report Date
    December 25, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEA
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER EXTUBATION WAS PERFORMED AS THE PATIENT HAD BEEN RECOVERED, A DOCTOR AT HOSPITAL CONFIRMED VOCAL CORD EDEMA AND REINTUBATION WAS PERFORMED. THE CUFF PRESSURE WAS MANAGED TO BE KEPT AROUND 25CMH20. THE REPORTER INDICATED THAT ADDITIONAL INFORMATION MAY BE PROVIDED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30986 MALLINCKRODT TAPERGUARD TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention