MAUDE Adverse Event Report: WALNUTCARES (BEARCARE) / BEARCARE, INC. WALNUT WEARABLE SMART THERMOMETER; THERMOMETER, CLINICAL COLOR CHANGE

Model Number WT20

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/30/2023

Event Type  Injury  

Event Description

Walnutcares wearable thermometer burned my baby.

• Brand Name: WALNUT WEARABLE SMART THERMOMETER
• Type of Device: THERMOMETER, CLINICAL COLOR CHANGE
• Manufacturer (Section D): WALNUTCARES (BEARCARE) / BEARCARE, INC.
• MDR Report Key: 17604610
• MDR Text Key: 321886499
• Report Number: MW5144872
• Device Sequence Number: 1
• Product Code: FQZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: WT20
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White