MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for NETI POT manufactured by Neilmed Pharmaceuticals, Inc..
[65940985]
After using the neti pot for sinus congestion i developed a very sore throat that wouldn't go away. I finally had a throat culture done and it showed i had an overgrowth of yeast. It was from the constant irrigation of my nose/throat and it rinsed all the "good bacteria" away and pre-disposed me to developing a throat yeast infection. Date of use: (b)(6) 2013 - (b)(6) 2017. Diagnosis or reason for use: chronic nasal congestion, sinusitis. Is the product over-the-counter: yes. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067449 |
| MDR Report Key | 6278908 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-01-24 |
| Date of Event | 2013-01-11 |
| Date Added to Maude | 2017-01-26 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NETI POT |
| Generic Name | APPPLICATOR, ENT |
| Product Code | KCJ |
| Date Received | 2017-01-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED PHARMACEUTICALS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-24 |