MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-09 for NEIL MED SINUS RINSE KIT M110114 manufactured by Neilmed.
[5866574]
I do not know exactly what happened. I remember burning and drowning sensation. My eyes and teeth. Pain. I think i almost died. I still am having severe visual problems and my head - my whole head is swimming. Nothing came down into the mouth - i think it went into the sinus cavity instead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043218 |
| MDR Report Key | 4867581 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-08 |
| Date Added to Maude | 2015-06-26 |
| 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 | NEIL MED SINUS RINSE KIT |
| Generic Name | NEIL MED SINUS RINSE KIT |
| Product Code | KCJ |
| Date Received | 2015-06-09 |
| Model Number | M110114 |
| Lot Number | 2017-11 |
| ID Number | 2000-2014 |
| Device Expiration Date | 2017-11-30 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-06-09 |