BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 18704204 · Received February 13, 2024

    Report

    Report Number
    MW5151566
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 7, 2024
    Manufacturer
    HAPPIEST BABY, INC.
    Product Code
    QTG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE USING THE SNOO WITH THE LEG LIFTERS ON AND THE OLD STYLE OF SLEEP SACK. THE INCLINE AND MOVEMENT AND LACK OF LEG STRAP IN THE OLD STYLE OF SNOO SACK MADE HIM SLIDE DOWN IN THE SACK AND I WOKE UP TO IT COVERING HIS MOUTH AND HIS NOSE. HE COULD HAVE SUFFOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157768 SNOO SMART SLEEPER INFANT SUPINE SLEEP SYSTEM QTG HAPPIEST BABY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Life Threatening