MAUDE Adverse Event Report: SHENZHEN TESLONG TECHNOLOGY CO., LTD WALNUT CARES; WALNUT WEARABLE SMART THERMOMETER

Model Number WT20

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2023

Event Type  Injury  

Event Description

Letter from consumer received on april 17, 2023, suggesting that on (b)(6) 2023, a child wearing the product suffered third-degree burns to the chest, which they believe was caused by the product's battery.

• Brand Name: WALNUT CARES
• Type of Device: WALNUT WEARABLE SMART THERMOMETER
• Manufacturer (Section D): SHENZHEN TESLONG TECHNOLOGY CO., LTD; 2nd floor, block 4; jinhuafa industrial park; shenzhen, guandong 51810 9; CH 518109
• Manufacturer (Section G): SHENZHEN TESLONG TECHNOLOGY CO., LTD; 2nd floor, block 4; jinhuafa industrial park; shenzhen, guandong 51810 9; CH 518109
• Manufacturer Contact: dongshen chen ; 80 davids dr. #200; hauppauge, NY 11788
• MDR Report Key: 17948918
• MDR Text Key: 325827733
• Report Number: 3015140201-2023-00002
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WT20
• Device Lot Number: 20221115W002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92275
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 9 MO
• Patient Sex: Male