BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 6894888 · Received September 26, 2017

    Report

    Report Number
    9681900-2017-00036
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 7, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED INT THIS COMPLAINT HAS BEEN RECEIVED BY THE MANUFACTURER. HOWEVER THE INVESTIGATION OF SAID DEVICE IS STILL ON GOING AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WAS NOT RETURNED TO MANUFACTURER. DEVICE NOT RETURNED TO MANUFACTURER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PATIENT WAS BEING "BAGGED" IN THE PACU WHEN THE 15 MM CONNECTOR BROKE OFF. A NEW LMA WAS PLACED TO ASSURE THE AIRWAY WAS SECURE". IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE PATIENT WAS BEING "BAGGED" IN THE PACU WHEN THE 15MM CONNECTOR BROKE OFF. A NEW LMA WAS PLACED TO ASSURE THE AIRWAY WAS SECURE". IT WAS REPORTED THERE WAS NO INJURY TO THE PATIENT. PATIENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673843 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8WTAABBK

    Patients

    Seq Age Sex Outcome Treatment
    1