BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LO W/LANZ 7.5MM

    MDR report key: 1611885 · Received February 11, 2010

    Report

    Report Number
    2936999-2010-00086
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    January 1, 2010
    Report Date
    January 13, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K791045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CALLER REPORTED THE PILOT BALLOON ON THE TUBE LEAKED. THE PATIENT WAS NOT RE INTUBATED HOWEVER THE PILOT LINE WAS CUT AND A REPAIR KIT WAS PUT ON THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-LO W/LANZ 7.5MM ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention