MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-10 for NEILMED NASOGEL 30ML SZ manufactured by Neilmed.
[4294534]
(b)(4), 30ml size, lot ngs259 (the "g" might be a "6"), expiration date march 2015, purchased from (b)(6) on (b)(6) 2014. I used it and it had an odd odor somewhat like unset epoxy resin. I looked inside and it has a yellow or light brown color. (b)(4) offered a replacement, but won't anser questions about contamination. I'm concerned about what i put in my body. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034914 |
| MDR Report Key | 3677477 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-02-24 |
| Date Added to Maude | 2014-03-14 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEILMED NASOGEL 30ML SZ |
| Generic Name | NASOGEL |
| Product Code | KCJ |
| Date Received | 2014-03-10 |
| Lot Number | NGS259 |
| Device Expiration Date | 2015-03-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-10 |