MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-11 for NEIL MED SINUGATOR manufactured by Neilmed Pharmaceuticals, Inc..
[108241008]
Neilmed sinugator caused a dura tear. Cerebrospinal fluid is leaking from the brain. May require surgical repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077177 |
| MDR Report Key | 7510644 |
| Date Received | 2018-05-11 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-05-06 |
| Date Added to Maude | 2018-05-14 |
| 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 | 3 |
| 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 | NEIL MED SINUGATOR |
| Generic Name | IRRIGATOR POWERED NASAL |
| Product Code | KMA |
| Date Received | 2018-05-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEILMED PHARMACEUTICALS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2018-05-11 |