BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU SIZE 5

    MDR report key: 3753010 · Received February 5, 2014

    Report

    Report Number
    9681900-2014-00005
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    TELEFLEX MED ASIA PTE LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PILOT BALLOON RUPTURED DURING INFLATION. THE ALLEGED ISSUE OCCURRED DURING THE TESTING PROCEDURE PRIOR TO PATIENT USE. NO PATIENT INJURY/HARM. NO REPORT OF A DELAY IN TREATMENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74707 LMA FLEXIBLE, REU SIZE 5 LARYNGEAL MASK AIRWAY CAE TELEFLEX MED ASIA PTE LTD 9FPAASXH

    Patients

    Seq Age Sex Outcome Treatment
    1