BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWLET DREAM SOCK

    MDR report key: 24617638 · Received March 16, 2026

    Report

    Report Number
    MW5185301
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 11, 2026
    Manufacturer
    OWLET BABY CARE
    Product Code
    QYU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED THE OWLET BEFORE MY CHILD ARRIVED IN (B)(6) 2024, A FEW MONTHS IN MY SENSOR WENT DEAD SO I USED THE WARRANTY TO RECEIVE A REPLACEMENT. THE NEW SENSOR HAS ALSO NOW GONE DEAD IN LESS THAN A YEAR. THE WARRANTY IS SUPPOSED TO COVER THESE DEVICES FOR UP TO A YEAR BUT I AM BEING TOLD THAT IS NO LONGER THE CASE. I'VE SEEN REPORTS ONLINE OF MANY OTHERS SUFFERING WITH FAULTY SENSORS THAT DIE AFTER A FEW MONTHS. WITH THIS PRODUCT BEING AS EXPENSIVE AS IT IS, I WOULD APPRECIATE IF THEY WOULD UPHOLD THEIR WARRANTY OR ENSURE THEIR PRODUCTS WERE BUILT TO LAST THAT TIME FRAME. I FEEL THEY ARE CUTTING CORNERS AND USING CHEAP PRODUCTS WHEN IT COME TO BABIES LIVES WHICH IS UNACCEPTABLE. PT CODE: 4582. DEVICE CODE: 1057. REFERENCED REPORT-MW5185300.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673338 OWLET DREAM SOCK INFANT PULSE RATE AND OXYGEN SATURATION MONITOR FOR OVER-THE-COUNTER USE QYU OWLET BABY CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female