BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROBERTAZZI NASAL AIRWAY

    MDR report key: 2110950 · Received May 4, 2011

    Report

    Report Number
    8040412-2011-00052
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNK SAMPLE IS AVAILABLE FOR INVESTIGATION, THEREFORE, INVESTIGATION IS INCOMPLETE. A F/U INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE NASAL AIRWAY BECAME LODGED IN THE BACK OF THE PT'S THROAT. THE ALLEGED INCIDENT WAS DISCOVERED WHEN AN ATTEMPT WAS BEING MADE TO INTUBATE THE PT IN THE OPERATING ROOM. THE PT WAS BEING PREVIOUSLY MONITORED IN THE ICU DEPT PRIOR TO GOING TO THE OPERATING ROOM. THE NASAL AIRWAY WAS REMOVED SURGICALLY WITH NO CONSEQUENCE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBERTAZZI NASAL AIRWAY NASOPHARYNGEAL AIRWAY BTQ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK