BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 5

    MDR report key: 3820854 · Received April 15, 2014

    Report

    Report Number
    9681900-2014-00016
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THERE WAS A SMALL PIN HOLE OBSERVED AT THE BASE OF THE CUFF. THE CUFF FAILED TO MAINTAIN INFLATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230483 LMA FLEXIBLE, REU, SIZE 5 LARYNGEAL MASK AIRWAY CAE TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1