MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-08 for SUMATRIPTAN NOSE SPRAY manufactured by Unk.
[102115658]
Reporter stated that the nasal spray valve is so hard to push. When both and her husband tried, they could not get it in the right direction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075782 |
| MDR Report Key | 7327232 |
| Date Received | 2018-03-08 |
| Date of Report | 2018-03-08 |
| Date of Event | 2017-12-03 |
| Date Added to Maude | 2018-03-09 |
| 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 | PATIENT |
| 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 | 3 |
| Brand Name | SUMATRIPTAN NOSE SPRAY |
| Generic Name | APPLICATOR, ENT |
| Product Code | KCJ |
| Date Received | 2018-03-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-08 |