BEUDAMED
    FDA Adverse Event Other Summary report: N

    LNOP NEO BRIDGE AND LNOP NEO-L

    MDR report key: 543510 · Received August 16, 2004

    Report

    Report Number
    543510
    Event Type
    Other
    Date Received
    August 16, 2004
    Date of Event
    July 25, 2004
    Report Date
    August 16, 2004
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS AN EXAMPLE OF 1 OF 5 INCIDENTS OF PATIENTS EXPERIENCING SMALL BLISTERS ON FINGERS OR TOES DURING THE USE OF PULSE OXIMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LNOP NEO BRIDGE AND LNOP NEO-L SPO2 ADHESIVE SENSOR DQA MASIMO CORPORATION CE 0123 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO