BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASIMOSET LNCS TC-I SPO2 REUSABLE EAR SENSOR

    MDR report key: 11990730 · Received June 14, 2021

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    Report

    Report Number
    11990730
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 7, 2021
    Product Code
    DPZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NARRATIVE FROM STAFF: THE PATIENT WAS FOUND WITH AN UNSTAGEABLE PRESSURE INJURY TO THE RIGHT NARIS RELATED TO AN OXYGEN SENSOR CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890898 MASIMOSET LNCS TC-I SPO2 REUSABLE EAR SENSOR OXIMETER, EAR DPZ 1895 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA Required Intervention