FDA Adverse Event
Injury
Summary report: N
BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
MDR report key: 15429425
·
Received September 15, 2022
Report
- Report Number
- 3016525500-2022-00010
- Event Type
- Injury
- Date Received
- September 15, 2022
- Report Date
- August 31, 2022
- Manufacturer
- BIGFOOT BIOMEDICAL, INC
- Product Code
- QLG
- UDI-DI
- 00850003506388
- Removal / Correction Number
- N/A
- 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 |
|---|---|---|---|---|---|---|---|
| 242446 | BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM | DIABETES MANAGEMENT SYSTEM | QLG | BIGFOOT BIOMEDICAL, INC | FG-300204 | 5547 | 00850003506388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other |