BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURAPLEX 36619 NPA KIT

    MDR report key: 8217952 · Received January 4, 2019

    Report

    Report Number
    3004986234-2018-00002
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    August 15, 2018
    Report Date
    January 4, 2019
    Manufacturer
    WELL LEAD MEDICAL CO. LTD
    Product Code
    BTQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMS PROVIDER INSERTED A 26F NPA FROM A CURAPLEX 36619 NPA KIT INTO A PATIENT SUFFERING FROM A HEROIN OVERDOSE. UPON REGAINING CONSCIOUSNESS, THE PATIENT BEGAN SNORTING THE NPA AND THE DEVICE WAS SUCKED INTO THE PATIENT'S NASAL CAVITY CAUSING THE PATIENT TO COMPLAIN HE WAS BEING GAGGED. SUBSEQUENTLY, THE PATIENT WAS TRANSPORTED TO THE ER TO HAVE THE NPA REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11137 CURAPLEX 36619 NPA KIT AIRWAY, NASOPHARYNGEAL AIRWAY BTQ WELL LEAD MEDICAL CO. LTD 36619 ASM0020726

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention