BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER HI-LO 7.5MM BX10

    MDR report key: 1649394 · Received March 30, 2010

    Report

    Report Number
    2936999-2010-00572
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    August 28, 2009
    Report Date
    March 1, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K965132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    ON (B) (6) 2010, A REPORT WAS FOUND ON THE FDA WEBSITE MAUDE DESCRIBING THE FOLLOWING: EVENT DATE: (B) (6) 2009. EVENT TYPE: INJURY. PT OUTCOME: LIFE THREATENING; HOSPITALIZATION REQUIRED, INTERVENTION DISABILITY OTHER. EVENT DESCRIPTION: CUFF FAILURE ON THE ENDOTRACHEAL TUBE. PT DESATURATED ON THE VENT. CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTER HI-LO 7.5MM BX10 ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention