OWLET DREAM SOCK

Description of Event or Problem

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.