MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-02 for ADVAIR DISKUS manufactured by .
[1228068]
Pt started using advair diskus in 2009. Reason for use: copd. Twenty days later, pt was taken to hosp via 911. Pt experienced breathing difficulties, weakness and lethargy. Pt says lungs felt like they were cemented. Md discontinued use. Hosp diagnosis. Pneumonia and bronchitis. Dose: unk. Frequency: unk. Route: unk. Dates of use: started 2009. Diagnosis: copd.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012560 |
| MDR Report Key | 1462586 |
| Date Received | 2009-09-02 |
| Date of Report | 2009-09-02 |
| Date of Event | 2009-08-21 |
| Date Added to Maude | 2009-09-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVAIR DISKUS |
| Generic Name | NONE |
| Product Code | KCO |
| Date Received | 2009-09-02 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-09-02 |