BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET INFANT PULSE OXIMETER

    MDR report key: 7344605 · Received March 15, 2018

    Report

    Report Number
    MW5075891
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 17, 2018
    Report Date
    February 20, 2018
    Manufacturer
    OWLET BABY CARE INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PARENTS HAVE USED A HOME PULSE OXIMETER MONITOR ON THEIR (B)(6) OLD INFANT'S FOOT SINCE BIRTH. HE BECAME VERY CRANKY AND HIS MOTHER NOTED A BURN NEAR THE BALL OF HIS FOOT, WHERE THE SENSOR IS PLACED. THE ONE INCH BY ONE-HALF INCH BURN WAS PRIMARILY FIRST DEGREE, WITH A SMALL SECOND DEGREE IN THE CENTER. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183463 OWLET INFANT PULSE OXIMETER PULSE OXIMETER DQA OWLET BABY CARE INC. OBS 1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO