BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER - SENSOR

    MDR report key: 5666631 · Received May 19, 2016

    Report

    Report Number
    2244861-2016-00005
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 19, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINGLE PATIENT DISPOSABLE DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED TO A COMPANY REPRESENTATIVE THAT A (B)(6) PREEMIE PATIENT IN THE PICU APPEARS TO HAVE REDNESS AND SKIN DAMAGE MARKS AFTER MONITORING WITH A SMALL NON-ADHESIVE SENSOR AFTER A 3-DAY PERIOD. A FOLLOW-UP VISIT TO THE FACILITY, 4 DAYS LATER, PRODUCED ANOTHER PHOTOGRAPH THAT SHOWS SOME IMPROVEMENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322157 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER - SENSOR SMALL NON-ADHESIVE SENSOR MUD CAS MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 MO Required Intervention