BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE-SIGHT ELITE SMALL ADHESIVE SENSOR

    MDR report key: 6566258 · Received May 15, 2017

    Report

    Report Number
    2244861-2017-00001
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 11, 2017
    Report Date
    May 12, 2017
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    MUD
    UDI-DI
    10609538711012
    PMA / PMN Number
    K143675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NEONATE PATIENT WAS FOUND WITH RED MARKS ON THE FOREHEAD AFTER A SMALL STO2 SENSOR WAS REMOVED FOR AN APPLICATION SITE CHECK OR SENSOR REMOVAL. THE USE OF THE SENSOR WAS NOT CONSISTENT WITH THE USER DIRECTIONS AND MAY HAVE BEEN UN-CHECKED FOR AN EXTENDED PERIOD OF TIME. THIS WAS A MINOR INCIDENT AND THE CLINICIANS, INCLUDING A SKIN WOUND SPECIALIST, WERE NOT OVERLY CONCERNED ABOUT THE OUTCOME. THERE IS NO RECORD OF MEDICAL INTERVENTION AND A SERIES OF PHOTOGRAPHS 2-3 DAYS APART SHOW IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347699 FORE-SIGHT ELITE SMALL ADHESIVE SENSOR TISSUE OXIMETER MUD CAS MEDICAL SYSTEMS, INC. 01-07-2101 UNK 10609538711012

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other