BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 7300341 · Received February 27, 2018

    Report

    Report Number
    9681900-2018-00017
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 2, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    PMA / PMN Number
    K780900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE CUFF DOES NOT INFLATE. ALLEGED ISSUE REPORTED AS DETECTED PRIOR TO A PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY. THERE WAS NO REPORT OF NECESSARY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144281 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL 8WRABLRH

    Patients

    Seq Age Sex Outcome Treatment
    1