BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX NASOPHARYNGEAL AIRWAY

    MDR report key: 8217941 · Received January 4, 2019

    Report

    Report Number
    3004986234-2018-00003
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    September 18, 2018
    Report Date
    January 4, 2019
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    BTQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO DIFFERENT INSTANCES WHERE THE NPA WAS SUCKED INTO THE PATIENT'S NASAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10945 CURAPLEX NASOPHARYNGEAL AIRWAY AIRWAY, NASOPHARYNGEAL AIRWAY BTQ WELL LEAD MEDICAL CO. LTD 51150, 51151, 51153, 51159, 51161 1611011715, 1607011182, 140501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention