BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-LO 7.5MM

    MDR report key: 1618645 · Received February 26, 2010

    Report

    Report Number
    2936999-2010-00227
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 2, 2010
    Manufacturer
    COVIDIEN/ FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K871204
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE THEY CONFIRMED ASYMMETRICAL INFLATION OF THE CUFF. A NON-ROUTINE REPLACEMENT OF THE TUBE WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention