BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNOP NEO-L

    MDR report key: 4251798 · Received November 6, 2014

    Report

    Report Number
    2031172-2014-00377
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 21, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MINOR SKIN DAMAGE AT THE SENSOR PLACEMENT AREA. THE SENSOR WAS PLACED ON THE BOTTOM OF PATIENT'S RIGHT FOOT. AFTER 7 HOURS, NURSE FOUND REDNESS (APPROXIMATED 5 MM) AND SLIGHT SKIN PEELING AFTER ATTEMPTING TO REMOVE THE SENSOR. THE AFFECTED SITE HEALED BY ITSELF WITHOUT ANY MEDICAL INTERVENTION. IT WAS CONFIRMED THAT PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714809 LNOP NEO-L OXIMETER DQA MASIMO CORPORATION 1798-1 14C05

    Patients

    Seq Age Sex Outcome Treatment
    1 54 DA