OWLET BABY CARE
Received Oct 20, 2025 · Event occurred Sep 19, 2025
Report 3012977166-2025-00002 · MDR key 23337198
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
- Adverse Event Without Identified Device or Use Problem
Patient
14 DA · Female
- Abrasion
- Laceration(s)
- Abrasion
- Laceration(s)
Narrative
Additional Manufacturer Narrative
OWLET CONDUCTED A THOROUGH ASSESSMENT OF THE LACERATION EXPERIENCED BY THE BABY, AS WELL AS A HISTORICAL DATA ANALYSIS OF THE DEVICE. THE DEVICE FUNCTIONALITY PERFORMED AS INTENDED WITH NO DEFICIENCY OR MALFUNCTION IDENTIFIED. THE LACERATION OCCURRED ON THE OPPOSITE FOOT THAT THE SOCK WAS WORN, DUE TO THE BABY RUBBING HER FEET TOGETHER. THE RISK PROFILE WAS REVIEWED. THIS EVENT DID NOT INTRODUCE A NEW OR INCREASED RISK.
Description of Event or Problem
CUSTOMER REPORTED THAT THE SOCK'S VELCRO CAUSED CUTS TO THEIR BABY'S FOOT. BABY WAS WEARING THE SOCK ON THE LEFT FOOT WHEN THE VELCRO RUBBED AGAINST THE RIGHT FOOT OVERNIGHT, RESULTING IN LACERATIONS.
Remedial action
- Replace