BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4

    MDR report key: 4156077 · Received October 2, 2014

    Report

    Report Number
    9681900-2014-00058
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 WAS OBSERVED TO BE LEAKING AT THE SEAM OF THE CUFF DURING A PROCEDURE. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. PROCEDURE: INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614104 LMA PROSEAL, REU, SIZE 4 LARYNGEAL MASK AIRWAY BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1