BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 8769198 · Received July 8, 2019

    Report

    Report Number
    3010150334-2019-00003
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    November 8, 2017
    Report Date
    July 8, 2019
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    PMA / PMN Number
    K171423
    Removal / Correction Number
    3010150334-50819-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INTUBATED ON THE (B)(6) - 3 DAYS LATER THE SENSOR WAS REMOVED FROM THE RIGHT NARES AND THE LESION WAS NOTED - BETWEEN NURSING AND RT THEY ESTIMATE THE SENSOR HAD BEEN IN PLACE 26-28 HOURS. WOUND CARE WAS CONSULTED AND NOTED THE LESION TO BE .5X.7 PURPLE/BLACK WITH NO DRAINAGE. THE PATIENT HAS SINCE EXPIRED SO THERE IS NO FOLLOW UP ON THE WOUND. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563419 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE, SINGLE USE DQA XHALE ASSURANCE, INC 301-11214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention