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

Model Number WT20

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2023

Event Type  Injury  

Event Description

Email received form consumer dated april 11, 2023, suggesting that on (b)(6) 2023, a child wearing the product suffered significant skin burns.The complaint alleged that the child was asleep while wearing the product.Unknown at this time whether medical attention was necessary.

• Brand Name: WALNUT CARE
• Type of Device: WALNUT WEARABLE 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, bl;ock 4; jinhuafa industrial park; shenzhen, guandong 51810 9; CH 518109
• Manufacturer Contact: dongshen chen ; 80 davids dr. #200; hauppauge 11788
• MDR Report Key: 17949354
• MDR Text Key: 325838692
• Report Number: 3015140201-2023-00003
• 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: 04/11/2023

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: 04/11/2023
• 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
• Patient Age: 2 YR
• Patient Sex: Male