BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWLET DREAM SOCK

    MDR report key: 23923493 · Received December 30, 2025

    Report

    Report Number
    MW5181464
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 22, 2025
    Manufacturer
    OWLET BABY CARE, INC.
    Product Code
    QYU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED AN OWLET DREAM SOCK (FDA-CLEARED INFANT PULSE OXIMETER, MODEL/SENSOR SERIAL # (B)(6) FROM TARGET ON (B)(6) 2025 AS A BRAND-NEW, SEALED UNIT. AFTER 9 MONTHS THE SENSOR STOPPED WORKING AND OWLET CUSTOMER SERVICE SAYS THE DEVICE WAS ACTIVATED IN THEIR SYSTEM ON (B)(6) 2024 (ALMOST A YEAR PRIOR TO ME PURCHASING) OWLET SUPPORT CONFIRMED THIS PRE-ACTIVATION VOIDS THE 1-YEAR WARRANTY AND REFUSED SERVICE, STATING IT WAS A RETAILER ISSUE. THIS SUGGESTS THE DEVICE SOLD AS NEW MAY HAVE BEEN PREVIOUSLY OPENED, USED, RETURNED, OR HANDLED--POTENTIALLY COMPROMISING ITS INTEGRITY AS A MEDICAL DEVICE INTENDED FOR ACCURATE PULSE RATE AND OXYGEN SATURATION MONITORING IN HEALTHY INFANTS. POSSIBLE CONCERNS INCLUDE: ¿ UNKNOWN PRIOR USE AFFECTING SENSOR CALIBRATION OR ACCURACY ¿ POTENTIAL CONTAMINATION OR WEAR ON SKIN-CONTACTING COMPONENTS ¿ REDUCED RELIABILITY FOR CRITICAL HEALTH NOTIFICATIONS NO ADVERSE EVENT HAS OCCURRED YET, BUT AS THIS IS A CLASS II MEDICAL DEVICE FOR INFANT VITAL SIGNS MONITORING, PRE-USE COULD POSE RISKS TO DEVICE PERFORMANCE AND INFANT SAFETY. THIS APPEARS TO BE A RECURRING ISSUE WITH RETAIL STOCK (E.G., TARGET RETURNS RESOLD AS NEW). I REQUEST FDA REVIEW OF DISTRIBUTION PRACTICES TO ENSURE DEVICES REACH CONSUMERS IN VERIFIED NEW CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100188 OWLET DREAM SOCK INFANT PULSE RATE AND OXYGEN SATURATION MONITOR FOR OVER-THE-COUNTER USE QYU OWLET BABY CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male