BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4

    MDR report key: 3851507 · Received March 25, 2014

    Report

    Report Number
    9681900-2014-00012
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    TELEFLEX ASIA PTE LTD
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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 THAT THE ET TUBE CUFF WAS NOT HOLDING AIR. THERE WAS NO CONFIRMATION THAT THERE WAS PATIENT INVOLVEMENT DURING THE REPORTED DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173912 LMA PROSEAL, REU, SIZE 4 LARYNGEAL MASK AIRWAY CAE TELEFLEX ASIA PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1