MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-10 for NEILMED NASAL DEVICE WITH CHEMICAL manufactured by Neilmed Pharmaceuticals.
[75404712]
Neilmed was provided by (b)(6) clinic (b)(6) as medication for breathing causing exertion migraines and disability. There is a neilmed device for all ages. It is a improvised pressurized device or i. E. D. Simplified and terrorism capable. Dates are estimated in report. Injury, no first aid or medical attention received. Product category: toys & children. I certify that i have reviewed the report and that the info provided in this report is true and accurate to the best of my knowledge, info and belief: yes. Document number: (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069709 |
| MDR Report Key | 6562781 |
| Date Received | 2017-05-10 |
| Date of Report | 2017-04-25 |
| Date of Event | 2016-11-14 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEILMED NASAL DEVICE WITH CHEMICAL |
| Generic Name | NEILMED NASAL DEVICE WITH CHEMICAL |
| Product Code | KCJ |
| Date Received | 2017-05-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-10 |