BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 3 (100030)

    MDR report key: 7410914 · Received April 10, 2018

    Report

    Report Number
    9681900-2018-00023
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 19, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE "LMA WILL NOT DEFLATE". ALLEGED ISSUE REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".

    Additional Manufacturer Narrative · 1

    (B)(4). THE NUMBER OF USES OF THE DEVICE WAS NOT REPORTED. THIS INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. CUSTOMER REPORTED THE DEVICE IS NOT AVAILABLE TO RETURN FOR INVESTIGATION. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE "LMA WILL NOT DEFLATE". ALLEGED ISSUE REPORTED AS DETECTED DURING USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR CONSEQUENCE. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259054 LMA CLASSIC, REU, SIZE 3 (100030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:82NAFH4P

    Patients

    Seq Age Sex Outcome Treatment
    1