BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 4

    MDR report key: 4315317 · Received November 12, 2014

    Report

    Report Number
    9681900-2014-00065
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 11, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    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 THE DEVICE WOULD NOT STAY INFLATED DURING A PROCEDURE. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729874 LMA CLASSIC, REU, SIZE 4 LARYNGEAL MASK AIRWAY BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1