BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 6300068 · Received February 3, 2017

    Report

    Report Number
    9681900-2017-00009
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    December 16, 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 COULD NOT BE PERFORMED AS NO LOT OR SERIAL NUMBER WAS REPORTED. 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 STILL IN PROGRESS AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT "THE CONNECTOR SHEARED OFF WHEN DISCONNECTING FROM THE CATHETER MOUNT". IT WAS REPORTED THE ALLEGED EVENT OCCURRED DURING TRANSFER FROM THE THEATRE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT "THE CONNECTOR SHEARED OFF WHEN DISCONNECTING FROM THE CATHETER MOUNT". IT WAS REPORTED THE ALLEGED EVENT OCCURRED DURING TRANSFER FROM THE THEATRE. IT WAS REPORTED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83437 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER MOUNT