BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2963184 · Received February 11, 2013

    Report

    Report Number
    2936999-2013-00083
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    REPORTER STATES THAT THE CUFF DOES NOT MAINTAIN PRESSURE. REPORTER CONFIRMED THAT PATIENT WAS DECANNULATED AND RECANNULATED WITH A REPLACEMENT TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59580 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE JOH COVIDIEN, FORMERLY TYCOHEALTHCARE 201209403

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention