BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 5 (110050)

    MDR report key: 6352687 · Received February 23, 2017

    Report

    Report Number
    9681900-2017-00012
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 2, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER CORRECTED TO TELEFLEX MEDICAL, (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.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "DEVICE WILL NOT INFLATE/DEFLATE CORRECTLY." ALLEGED DEFECT DETECTED PRIOR TO PATIENT USE, DURING FUNCTIONAL TESTING. NO REPORT OF HARM OR INJURY TO PATIENT. NO REPORT OF DELAY IN TREATMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THAT THE "DEVICE WILL NOT INFLATE/DEFLATE CORRECTLY." ALLEGED DEFECT DETECTED PRIOR TO PATIENT USE, DURING FUNCTIONAL TESTING. NO REPORT OF HARM OR INJURY TO PATIENT. NO REPORT OF DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136959 LMA FLEXIBLE, REU, SIZE 5 (110050) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 9FRAAU5X

    Patients

    Seq Age Sex Outcome Treatment
    1