FDA Adverse Event
Injury
Summary report: N
WALNUT CARES
MDR report key: 17949359
·
Received October 17, 2023
Report
- Report Number
- 3015140201-2023-00004
- Event Type
- Injury
- Date Received
- October 17, 2023
- Report Date
- March 30, 2023
- Manufacturer
- SHENZHEN TESLONG TECHNOLOGY CO., LTD
- Product Code
- FLL
- Removal / Correction Number
- 92275
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
EMAIL RECEIVED FROM CONSUMER ON MARCH 30, 2023, SUGGESTING THAT ON AN UNSPECIFIED DATE, A CHILD WEARING THE PRODUCT EXPERIENCED SKIN IRRITATION. NO FURTHER DETAILS WERE PROVIDED BY THIS CONSUMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2078414 | WALNUT CARES | WALNUT WEARABLE THERMOMETER | FLL | SHENZHEN TESLONG TECHNOLOGY CO., LTD | WT20 | 20221115W002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |