MAUDE Adverse Event Report: OWLET BABY CARE OWLET SOCK; OXIMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

We noticed our baby has a burn to her foot from the owlet sock.Fei: (b)(4).

• Brand Name: OWLET SOCK
• Type of Device: OXIMETER
• Manufacturer (Section D): OWLET BABY CARE
• MDR Report Key: 16246891
• MDR Text Key: 308246487
• Report Number: MW5114505
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Sex: Female