MAUDE Adverse Event Report: WALNUT THERMOMETER; THERMOMETER, CLINICAL COLOR CHANGE

Device Problems Corroded (1131); Material Rupture (1546); Battery Problem (2885)

Patient Problems Erythema (1840); Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 04/10/2023

Event Type  Injury  

Event Description

A 2 year old child was wearing a walnut cares wearable bluetooth thermometer to monitor temperature while sleeping for a common cold.Upon removing the thermometer in the morning, corrosion was noticed around the contact sensor and charging contacts, similar to battery acid.We immediately checked the child's skin and discovered a blistered and scabbed chemical burn with significant redness and irritation around the burn site.It appears the battery inside the walnut device ruptured during wear and caused a chemical burn.We took the child to their pcp, who confirmed a 2nd degree chemical burn caused by the device.We have reached out to walnut cares via their customer contact email (info@walnutcares.Com) and have not received a response.

• Brand Name: WALNUT THERMOMETER
• Type of Device: THERMOMETER, CLINICAL COLOR CHANGE
• MDR Report Key: 16763797
• MDR Text Key: 313593275
• Report Number: MW5116762
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ZYRTEC
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 13 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White