Brand Name | WALNUT CARES |
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, block 4 |
jinhuafa industrial park |
shenzhen, guandong 51810 9 |
CH
518109
|
|
Manufacturer Contact |
dongsheng
chen
|
80 davids dr. #200 |
hauppage, NY 11788
|
|
MDR Report Key | 17949359 |
MDR Text Key | 325838701 |
Report Number | 3015140201-2023-00004 |
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 |
03/30/2023 |
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 Model Number | WT20 |
Device Lot Number | 20221115W002 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/30/2023 |
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 |
|
|