BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA SUPREME, SU, SIZE 4

    MDR report key: 4142718 · Received September 24, 2014

    Report

    Report Number
    9681900-2014-00057
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 AIR WAS LEAKING AFTER THE LMA DEVICE WAS CONNECTED TO THE RESPIRATOR. CUSTOMER CHECKED THE MASK AND FOUND A BREAKAGE AT THE CONNECTING SITE OF THE BITE BLOCK. THE REPORTED DEFECT WAS FOUND DURING PATIENT USE. THERE WAS NO REPORTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593778 LMA SUPREME, SU, SIZE 4 LARYNGEAL MASK AIRWAY BTR TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1