MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-14 for NUVAGEN 9066385 789564 manufactured by Belcher Pharmaceuticals,llc.
[92803395]
Patient recovered.
Patient Sequence No: 1, Text Type: N, H10
[92803396]
Patient has experience with headache.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000526113-2017-00001 |
| MDR Report Key | 7029116 |
| Date Received | 2017-11-14 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-11-02 |
| Device Manufacturer Date | 2017-01-02 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUVAGEN |
| Generic Name | NUVAGEN COLLAGEN POWDER |
| Product Code | KOZ |
| Date Received | 2017-11-14 |
| Model Number | 9066385 |
| Catalog Number | 789564 |
| Lot Number | 123456 |
| Device Expiration Date | 2017-07-02 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELCHER PHARMACEUTICALS,LLC |
| Manufacturer Address | 6911 BRYAN DAIRY ROAD LARGO FL 337771714 US 337771714 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-14 |