FDA Adverse Event
Injury
Summary report: N
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
MDR report key: 15588092
·
Received October 12, 2022
Report
- Report Number
- 3016525500-2022-00012
- Event Type
- Injury
- Date Received
- October 12, 2022
- Report Date
- August 26, 2022
- Manufacturer
- BIGFOOT BIOMEDICAL, INC
- Product Code
- QLG
- UDI-DI
- 00850003506258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2923770 | BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM | DIABETES MANAGEMENT SYSTEM | QLG | BIGFOOT BIOMEDICAL, INC | FG-300188 | 14031 | 00850003506258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Other |