BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4

    MDR report key: 3904701 · Received May 27, 2014

    Report

    Report Number
    9681900-2014-00018
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 16, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    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 WOULD INFLATE BUT WOULD NOT REMAIN INFLATED DURING USE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311944 LMA CLASSIC, REU, SIZE 4 LARYNGEAL MASK AIRWAY BTR TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1