MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for INHALER manufactured by Unk.
[102500001]
Hard to dispense correctly due to spray shooting into tongue lessening dosage, causing dry mouth and lips. Attached cover gets in the way when dispensing. Also design makes it difficult to fit in a woman's purse. My "proair" was perfect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075866 |
| MDR Report Key | 7337571 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-03-02 |
| Date Added to Maude | 2018-03-14 |
| 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 |
| 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 | INHALER |
| Generic Name | INHALER |
| Product Code | KCO |
| Date Received | 2018-03-13 |
| Lot Number | V425 |
| Device Expiration Date | 2019-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2018-03-13 |