BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 2.5

    MDR report key: 3851586 · Received March 25, 2014

    Report

    Report Number
    9681900-2014-00011
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 THERE WAS HERNIATION OF THE CUFF DURING USE ON A PT. THERE WAS NO PT INJURY REPORTED. THE PT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173887 LMA FLEXIBLE, REU, SIZE 2.5 LARYNGEAL MASK AIRWAY CAE TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1