BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 3

    MDR report key: 3813399 · Received March 27, 2014

    Report

    Report Number
    9681900-2014-00014
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    TELEFLEX ASIA TE LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE WAS NOT HOLDING AIR DURING USE ON PT. THE PT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179863 LMA FLEXIBLE, REU, SIZE 3 LARYNGEAL MASK AIRWAY CAE TELEFLEX ASIA TE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1