MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-20 for NETI POT REV# 320100506 manufactured by Neilmed Pharmaceutical, Inc..
[5425426]
Using the push bottle neti pot, i filled it with tap water as the directions showed in the picture for weeks now, and have developed a very severe sinus infection. Because of it this is my second round of antibiotics the doctor has tried me on two different antibiotics now to clear the sinus infection. The neti pot puts pressure behind my ears and the water gets stuck in my nasal passages. I feel that because the directions are falsified and shows you just a picture, that because i was informed and proper i've developed an infection that is harder to kill than normal. I also had bleeding when using the neti pot, after i blew my nose not a lot but, i've never had bleeding before.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040403 |
| MDR Report Key | 4454429 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-20 |
| Date Added to Maude | 2015-01-27 |
| 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 | NETI POT |
| Generic Name | NETI POT |
| Product Code | KMA |
| Date Received | 2015-01-20 |
| Model Number | REV# 320100506 |
| Lot Number | 1108-ENU-US |
| ID Number | 6520384-6669059 |
| Device Expiration Date | 2010-01-01 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED PHARMACEUTICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-20 |