Brand Name | TRUE FOCUS |
Type of Device | SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER |
Manufacturer (Section D) |
TRIVIDIA HEALTH INC |
2400 nw 55th court |
fort lauderdale FL 33309 |
|
Manufacturer Contact |
karen
devincent
|
2400 nw 55th court |
fort lauderdale, FL 33309
|
|
MDR Report Key | 15735207 |
MDR Text Key | 307627261 |
Report Number | 1000113657-2022-00582 |
Device Sequence Number | 1 |
Product Code |
NBW
|
UDI-Device Identifier | 00021292008956 |
UDI-Public | (01)00021292008956 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131013 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer |
Reporter Occupation |
Other
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
11/04/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/28/2024 |
Device Model Number | STRIP, TF WGN 50CTMG/DL 956970 |
Device Lot Number | NA1018 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 10/11/2022 |
Initial Date Manufacturer Received |
10/11/2022 |
Initial Date FDA Received | 11/04/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|