MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-12 for ADVAIR DISKUS * manufactured by Glaxo Wellcome.
[20934054]
Pt says diskus made a funny clicking sound when advancing the dose. He did not think it was delivering the dose correctly. Design counter on "49" (11 had been used). Pharmacy replaced the unit with a new one and requests a new one from glaxo wellcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025319 |
| MDR Report Key | 399559 |
| Date Received | 2002-06-12 |
| Date of Report | 2002-06-12 |
| Date of Event | 2002-06-10 |
| Date Added to Maude | 2002-06-18 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVAIR DISKUS |
| Generic Name | INHALATION DELIVERY SYSTEM |
| Product Code | KCO |
| Date Received | 2002-06-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 4119107 |
| ID Number | * |
| Device Expiration Date | 2003-04-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 388612 |
| Manufacturer | GLAXO WELLCOME |
| Manufacturer Address | * RESEARCH TRIANGLE PARK NC 27709 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-06-12 |