BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA CLASSIC, REU, SIZE 3 (100030)

    MDR report key: 8424756 · Received March 15, 2019

    Report

    Report Number
    9681900-2019-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    February 21, 2019
    Report Date
    February 25, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT STATES "THEY WERE UNABLE TO INFLATE THE CUFF DURING USE. NO HARM TO PATIENT. REPLACED WITH ANOTHER UNIT TO PROCEED."

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT STATES "THEY WERE UNABLE TO INFLATE THE CUFF DURING USE. NO HARM TO PATIENT. REPLACED WITH ANOTHER UNIT TO PROCEED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216917 LMA CLASSIC, REU, SIZE 3 (100030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:82QAFT49

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.