BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE-SIGHT ELITE SMALL SENSOR

    MDR report key: 5750449 · Received June 27, 2016

    Report

    Report Number
    2244861-2016-00007
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 27, 2016
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    MUD
    PMA / PMN Number
    K143675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SINGLE PT. DISPOSABLE DEVICE WAS DISCARD.

    Description of Event or Problem · 1

    DURING ROUTINE MONITORING BRUISES ON THE PATIENTS BACK WERE NOTICED UPON REMOVAL OF THE SENSOR AFTER 4 DAYS OF MONITORING. THE ATTENDING CLINICIAN DESCRIBED THE INJURY AS MODERATE-SEVERE BRUISING ONCE EDEMA DECREASED. THIS WAS A VERY SICK, LOW BIRTHWEIGHT INFANT. THE RECORD SHOWS THAT THE PATIENT HAD PREVIOUSLY LAID ON TOP OF SENSOR, ADDING PRESSURE, AND A LIKELY CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407082 FORE-SIGHT ELITE SMALL SENSOR TISSUE OXIMETER SENSOR MUD CAS MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Required Intervention