BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2629441 · Received June 20, 2012

    Report

    Report Number
    2936999-2012-00276
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 29, 2012
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER # 118-75M IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE U.S. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K841872.

    Description of Event or Problem · 1

    CUSTOMER STATES: THE BALLOON DEFLATED WITHOUT APPARENT REASON. THE CALLER CONFIRMED THAT EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CUSTOMER BELIEVES THAT THE PROBLEM MAY BE IN THE BALLOON PILOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SAFETY FLEX CUFFED MURPHY BTO COVIDIEN/FORMERLY TYCO HEALTHCARE 201201714X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention