BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 5

    MDR report key: 4961263 · Received August 3, 2015

    Report

    Report Number
    9681900-2015-00048
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 29, 2015
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. ALL PROCESSES WERE EXECUTED ACCORDING TO THE STANDARD OPERATING METHODS.DUE TO THE LACK OF SAMPLE AVAILABLE THE COMPLAINT COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. THERE WILL BE CONTINUED MONITORING AND TRENDING ON ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS:THE CUSTOMER ALLEGES THE CONNECTOR RUPTURED.THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE CONNECTOR RUPTURED. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504211 LMA CLASSIC, REU, SIZE 5 LARYNGEAL MASK AIRWAY BTR THE LARYNGEAL MASK COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1