BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA UNIQUE

    MDR report key: 6971103 · Received October 24, 2017

    Report

    Report Number
    6971103
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 19, 2017
    Manufacturer
    TELEFLEX INC.
    Product Code
    CAE
    UDI-DI
    05060112313578
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CRNA WAS PREPARING FOR CASE AND LMA #3 WOULD NOT DEFLATE. CRNA OBTAINED ANOTHER LMA #3 WITH SAME RESULTS. COULD NOT DEFLATE LMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753521 LMA UNIQUE AIRWAY WITH CUFF PILOT¿ TECHNOLOGY, SIZE 3 CAE TELEFLEX INC. LQAFNB 05060112313578

    Patients

    Seq Age Sex Outcome Treatment
    1