MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for NUVAGEN manufactured by Belcher Pharmaceuticals, Llc.
[93142150]
Case description: this spontaneous report from a consumer received on 08-nov-2017 involved a/an patient, patient initials dd who started to receive[suspect_namemod]. The patient's medical history was not available. On an unspecified date the patient received first dose of[suspect_namemod]:[1] at administered via an unspecified route at a dose of for an unspecified indication. The patient developed/experienced rash. The patient's laboratory test results were not available. (describe medications, procedures, tests, investigations etc. ) following [treatment or dechallenge/rechallenge]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000526113-2017-70001 |
| MDR Report Key | 7038882 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-08 |
| Date Mfgr Received | 2017-11-08 |
| Date Added to Maude | 2017-11-16 |
| 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 |
| Product Code | KOZ |
| Date Received | 2017-11-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELCHER PHARMACEUTICALS, LLC |
| Manufacturer Address | 12393 BELCHER RD S STE 420 LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-16 |