BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6300060 · Received February 3, 2017

    Report

    Report Number
    9681900-2017-00010
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    October 27, 2016
    Report Date
    January 9, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF THE SAMPLE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS COMPLAINT IS IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE CONNECTOR OF THE LMA WAS "CONNECTOR SHEARED OFF". ALLEGED DEFECT REPORTED AS BEING DETECTED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE CONNECTOR OF THE LMA WAS "CONNECTOR SHEARED OFF". ALLEGED DEFECT REPORTED AS BEING DETECTED PRIOR TO USE. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84526 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8VRAETLF

    Patients

    Seq Age Sex Outcome Treatment
    1