BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2926299 · Received January 16, 2013

    Report

    Report Number
    2936999-2013-00035
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    May 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEAL, AVENDIA HENEQUEN
    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 STATES: AFTER 6 DAYS USE ON A PATIENT AT HOSPITAL, A DOCTOR CONFIRMED THE PATIENT DEVELOPED VOCAL CORD PARESIS AND GLOTTIC STENOSIS. INFORMATION PROVIDED SUGGEST THE REINTUBATION OF REPLACEMENT TUBE WAS REQUIRED. CUSTOMER CONFIRMED PRE-TEST WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24284 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCOHEAL, AVENDIA HENEQUEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention