BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RD SAT NEO

    MDR report key: 13416756 · Received January 31, 2022

    Report

    Report Number
    MW5107090
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    December 16, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEONATE WITH REDDENED SKIN IN AREA OF WHERE SKIN PROBE WAS APPLIED ON RIGHT WRIST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378422 RD SAT NEO OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female