OWLET BABY CARE
Received Feb 20, 2026 · Event occurred Apr 5, 2025
Report 3012977166-2026-00004 · MDR key 24408336
Device
Generic name
Owlet Dream Sock Plus Health Notifications
Manufacturer
Owlet Baby Care, Inc.Model number
DREAM SOCKProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
4 MO · Male
- Abrasion
- Blister
Narrative
Additional Manufacturer Narrative
OWLET CONDUCTED A THOROUGH ASSESSMENT OF THE CLOUD DATA IN RELATION TO THE BLISTER ON THE CHILD'S FOOT. THE HISTORICAL DATA LOGS PROVED THAT THE DEVICE PERFORM AS INTENDED, WITH NO MALFUNCTION, NO FAST BATTERY DISCHARGE, AND NO DEVICE HEAT-UP. THE TEMPERATURE SENSORS NOTED THE HIGHEST TEMPERATURE TO BE 36.5C, WHICH IS SKIN TEMPERATURE. THE LOCATION OF THE BLISTERS WAS ON THE BOTTOM OF THE TOES, WHICH WAS A RESULT FROM WIGGLING TOES CAUSING FRICTION BETWEEN THE SKIN AND THE FABRIC SOCK. OWLET ADVISES THE OWLET SOCK TO BE PLACED BEHIND THE TOES (PER IFU AND LABELLING INSTRUCTIONS) TO PREVENT FRICTION INJURIES TO THE SKIN. THE RISK PROFILE WAS REVIEWED, AND THE EVENT DID NOT INTRODUCE ANY NEW OR INCREASED RISK.
Description of Event or Problem
CUSTOMER REPORTED BLISTERS UNDERNEATH HIS CHILD'S TOES FROM WEARING THE OWLET DREAM SOCK.