BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET BABY CARE

    MDR report key: 24408336 · Received February 20, 2026

    Report

    Report Number
    3012977166-2026-00004
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    April 5, 2025
    Report Date
    February 20, 2026
    Manufacturer
    OWLET BABY CARE, INC.
    Product Code
    QYU
    PMA / PMN Number
    DEN220091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OWLET CONDUCTED A THOROUGH ASSESSMENT OF THE CLOUD DATA IN RELATION TO THE BLISTER ON THE CHILD'S FOOT. THE HISTORICAL DATA LOGS PROVED THAT THE DEVICE PERFORM AS INTENDED, WITH NO MALFUNCTION, NO FAST BATTERY DISCHARGE, AND NO DEVICE HEAT-UP. THE TEMPERATURE SENSORS NOTED THE HIGHEST TEMPERATURE TO BE 36.5C, WHICH IS SKIN TEMPERATURE. THE LOCATION OF THE BLISTERS WAS ON THE BOTTOM OF THE TOES, WHICH WAS A RESULT FROM WIGGLING TOES CAUSING FRICTION BETWEEN THE SKIN AND THE FABRIC SOCK. OWLET ADVISES THE OWLET SOCK TO BE PLACED BEHIND THE TOES (PER IFU AND LABELLING INSTRUCTIONS) TO PREVENT FRICTION INJURIES TO THE SKIN. THE RISK PROFILE WAS REVIEWED, AND THE EVENT DID NOT INTRODUCE ANY NEW OR INCREASED RISK.

    Description of Event or Problem · 0

    CUSTOMER REPORTED BLISTERS UNDERNEATH HIS CHILD'S TOES FROM WEARING THE OWLET DREAM SOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290137 OWLET BABY CARE OWLET DREAM SOCK PLUS HEALTH NOTIFICATIONS QYU OWLET BABY CARE, INC. DREAM SOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Other