MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-29 for NETI POTS manufactured by .
[2569487]
Saw on the tv news that neti pots are killing adults. Just wanted to make sure these are not being used by or for children rather than old-fashioned vaporizers. Are you going to issue a warning? Document (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023817 |
| MDR Report Key | 2421440 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-19 |
| Date Added to Maude | 2012-01-23 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NETI POTS |
| Generic Name | SINUS IRRIGATOR |
| Product Code | KAR |
| Date Received | 2011-12-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-29 |