BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOO

    MDR report key: 19618179 · Received June 25, 2024

    Report

    Report Number
    MW5156634
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 23, 2024
    Report Date
    June 23, 2024
    Manufacturer
    HAPPIEST BABY, INC.
    Product Code
    QTG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAPPIEST BABY SNOO BASSINET IS PUTTING SAFETY FEATURES BEHIND A PAYWALL/SUBSCRIPTION. IT IS STATED ON THEIR WEBSITE (SAFETY FEATURE #9) THAT YOU ARE ABLE TO CONTROL SNOO AND MODIFY SETTINGS REMOTELY. HOWEVER, WITH THEIR NEW SUBSCRIPTION, SOME OF THOSE SAFETY FEATURES WILL BE BEHIND A PAID FOR SUBSCRIPTION. I FEEL THE FDA SHOULD REEVALUATE ITS RECOMMENDATION FOR THIS PRODUCT WITH CERTAIN SAFETY FEATURES NOT BEING AVAILABLE TO ITS CONSUMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786520 SNOO INFANT SUPINE SLEEP SYSTEM QTG HAPPIEST BABY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown