BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2930342 · Received January 22, 2013

    Report

    Report Number
    2936999-2013-00050
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 10, 2012
    Report Date
    December 25, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEA
    Product Code
    BTR
    PMA / PMN Number
    K771219
    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 THE 1ST INTUBATION TOOK PLACE ON (B)(6) 2012 AND ON (B)(6) 2012, THE PATIENT DEVELOPED VOCAL CODE PARALYSIS AND SUBGLOTTIC NARROWING AND GRANULATION WAS OBSERVED AND REPLACEMENT OF THE TUBE WAS PERFORMED ON (B)(6) 2012. THE REPORTER INDICATED THAT ADDITIONAL INFORMATION RELATED TO THIS REPORT WILL BE PROVIDED WHEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30987 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCOHEA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention