MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-11 for QNASL NASAL SPRAY PUMP manufactured by Teva Pharmaceuticals.
[49505713]
The caller reported that she has been using the nasal aerosol pump spray since 2011 and recently started to give problems. It stopped spraying, locked up during use and not delivering. She notified the manufacturer but they will not comment on the issue or help.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063360 |
| MDR Report Key | 5790424 |
| Date Received | 2016-07-11 |
| Date of Report | 2016-07-11 |
| Date of Event | 2011-07-07 |
| Date Added to Maude | 2016-07-13 |
| 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 | 0 |
| Brand Name | QNASL NASAL SPRAY PUMP |
| Generic Name | QNASL NASAL SPRAY PUMP |
| Product Code | KCJ |
| Date Received | 2016-07-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-11 |