BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6908116 · Received October 2, 2017

    Report

    Report Number
    9681900-2017-00038
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 15, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER NAME AND ADDRESS CORRECTED. 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 · 1

    CUSTOMER COMPLAINT ALLEGES THE VALVE PORT WAS BROKEN. ALLEGED ISSUE REPORTED AS FOUND DURING INSPECTION/FUNCTIONAL TESTING PRIOR TO PATIENT USE. CUSTOMER SUBMITTED PHOTOS WITH THE COMPLAINT FOR REVIEW. THERE WAS NOT REPORT OF PATIENT HARM OR DELAY IN THERAPY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE VALVE PORT WAS BROKEN. ALLEGED ISSUE REPORTED AS FOUND DURING INSPECTION/FUNCTIONAL TESTING PRIOR TO PATIENT USE. CUSTOMER SUBMITTED PHOTOS WITH THE COMPLAINT FOR REVIEW. THERE WAS NOT REPORT OF PATIENT HARM OR DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688010 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SEPH07300732

    Patients

    Seq Age Sex Outcome Treatment
    1