BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3142932 · Received May 29, 2013

    Report

    Report Number
    2936999-2013-00413
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 31, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THERE WAS A PROXIMAL BALLOON INFLATION ISSUE IN THE AMBULANCE. DEVICE WAS REMOVED, ANOTHER ONE USED AND ONCE ARRIVED AT THE HOSPITAL, PT WAS INTUBATED. CUSTOMER REPORTED THAT INFORMATION RELATED TO PT IS UNK. NO PT INJURY OR ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233996 MALLINCKRODT COMBITUBE BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention