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 Type  Injury  

Event Description

On april 27, bearcare sent an amazon notification to all consumer who had purchased through amazon informing consumers of potential safety concerns and advising to cease use of the product.On (b)(6) 2023, a consumer who purchased the product on (b)(6) 2023, replied saying that her nephew "was burn (sic) using it." no further details were provided by the consumer.

• 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: dongsheng chen ; 80 davids dr. #200; hauppauge, NY 11788
• MDR Report Key: 17948905
• MDR Text Key: 325827833
• Report Number: 3015140201-2023-00001
• 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: 04/28/2023

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: 04/28/2023
• 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 Sex: Male