BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3676762 · Received February 26, 2014

    Report

    Report Number
    2936999-2014-00182
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 28, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS REC'D A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (A)NDA # K090352.

    Description of Event or Problem · 1

    CUSTOMER STATES: AFTER TWO DAYS USE ON A PT AT HOSPITAL, A NURSE CONFIRMED THE INFLATION LINE WAS BROKEN. NO PT HARM CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118083 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention