BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNCS NEO SENSOR

    MDR report key: 3766848 · Received April 12, 2014

    Report

    Report Number
    2031172-2014-00042
    Event Type
    Other
    Date Received
    April 12, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K111888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SENSOR AND LOT INFORMATION WERE NOT MADE AVAILABLE TO MASIMO FOR EVALUATION. THE HOSPITAL INDICATED THAT SINCE THEY WERE NOT AWARE OF THE COMPLAINT, THEY WOULD NOT HAVE KEPT THE SENSOR AND LOT INFORMATION IS NOT AVAILABLE. A REVIEW OF THE MATERIALS USED IN THIS SENSOR WAS CONDUCTED. SENSORS ARE MANUFACTURED WITH MATERIALS WHICH PASSED BIOCOMPATIBILITY TESTING. THIS INFORMATION WAS REVIEWED WITH THE CUSTOMER AND NO ADDITIONAL INFORMATION WAS REQUESTED. DURING A FOLLOW UP WITH THE PATIENT'S PARENT, IT WAS NOTED THAT THE PATIENT WAS PRESCRIBED A STEROID CREAM. THE PATIENT IS CURRENTLY HEALING BUT A RASH IS STILL PRESENT. PER THE DIRECTIONS FOR USE(DFU): THE LNCS SENSORS ARE CONTRAINDICATED FOR PATIENTS WHO EXHIBIT ALLERGIC REACTIONS TO FOAM RUBBER PRODUCTS AND/OR ADHESIVE TAPE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED SHE WAS INSTRUCTED BY NORTH COLLIER HOSPITAL IN (B)(6) TO CALL MASIMO REGARDING AN ALLERGIC REACTION HER CHILD WAS HAVING TO THE ADHESIVE FROM THE NEO SENSOR (#2329) TAPE. THE CUSTOMER WANTED TO KNOW WHAT ADHESIVE MATERIALS WERE USED, SO SHE COULD TELL THE EMERGENCY ROOM PERSONNEL. THE SENSOR WAS PLACED ON THE CHILD'S THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226317 LNCS NEO SENSOR DQA MASIMO CORPORATION LNCS NEO SENSOR

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other