BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET DREAM SOCK

    MDR report key: 20980109 · Received December 18, 2024

    Report

    Report Number
    MW5163762
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    December 10, 2024
    Report Date
    December 13, 2024
    Manufacturer
    OWLET BABY CARE, INC.
    Product Code
    QYU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE PUT THE OWLET DREAM SOCK ON MY SON AT NIGHT FOR THE LAST 4 MONTHS. ON THE NIGHT OF (B)(6) 2024, HE SUFFERED A 2ND DEGREE BURN, AS DIAGNOSED BY OUR PEDIATRICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628107 OWLET DREAM SOCK INFANT PULSE RATE AND OXYGEN SATURATION MONITOR FOR OVER-THE-COUNTER USE QYU OWLET BABY CARE, INC. BM06NMMCJ

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male