FDA Adverse Event
Injury
Summary report: N
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
MDR report key: 16065543
·
Received December 28, 2022
Report
- Report Number
- 3016525500-2022-00023
- Event Type
- Injury
- Date Received
- December 28, 2022
- Report Date
- January 17, 2023
- Manufacturer
- BIGFOOT BIOMEDICAL,.INC
- Product Code
- QLG
- UDI-DI
- 00850003506401
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2923772 | BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM | DIABETES MANAGEMENT SYSTEM | QLG | BIGFOOT BIOMEDICAL,.INC | FG-300206 | 20266 | 00850003506401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Unknown | Other |