FDA Adverse Event
Malfunction
Summary report: N
NUVAGEN
MDR report key: 7029116
·
Received November 14, 2017
Report
- Report Number
- 1000526113-2017-00001
- Event Type
- Malfunction
- Date Received
- November 14, 2017
- Date of Event
- November 2, 2017
- Report Date
- November 3, 2017
- Manufacturer
- BELCHER PHARMACEUTICALS,LLC
- Product Code
- KOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT RECOVERED.
Description of Event or Problem · 1
PATIENT HAS EXPERIENCE WITH HEADACHE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806708 | NUVAGEN | NUVAGEN COLLAGEN POWDER | KOZ | BELCHER PHARMACEUTICALS,LLC | 9066385 | 123456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |