BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OWLET BABY CARE

    MDR report key: 23337198 · Received October 20, 2025

    Report

    Report Number
    3012977166-2025-00002
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 20, 2025
    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 LACERATION EXPERIENCED BY THE BABY, AS WELL AS A HISTORICAL DATA ANALYSIS OF THE DEVICE. THE DEVICE FUNCTIONALITY PERFORMED AS INTENDED WITH NO DEFICIENCY OR MALFUNCTION IDENTIFIED. THE LACERATION OCCURRED ON THE OPPOSITE FOOT THAT THE SOCK WAS WORN, DUE TO THE BABY RUBBING HER FEET TOGETHER. THE RISK PROFILE WAS REVIEWED. THIS EVENT DID NOT INTRODUCE A NEW OR INCREASED RISK.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE SOCK'S VELCRO CAUSED CUTS TO THEIR BABY'S FOOT. BABY WAS WEARING THE SOCK ON THE LEFT FOOT WHEN THE VELCRO RUBBED AGAINST THE RIGHT FOOT OVERNIGHT, RESULTING IN LACERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354978 OWLET BABY CARE OWLET DREAM SOCK PLUS HEALTH NOTIFICATIONS QYU OWLET BABY CARE, INC. DREAM SOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Female Other