MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-26 for ADVAIR DISKUS manufactured by Glaxosmith Kline.
[19894360]
This has been the second time in the past few months that within 2 hours of using the inhaler he hasn't been able to breathe. Fortunately, he has a back-up inhaler that he has been able to use that helped him to breathe again and, because the back-up worked, he feels that the advair diskus inhalers of the same lot number are defective. He would like to know if others have complained of the same. He's been on this product for approximately 1 year. He has called the manufacturer to let them know that the product of this lot isn't working. The manufacturer has requested him to return the inhaler to them and they've authorized a replacement inhaler. The replacement is currently working without any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002804 |
| MDR Report Key | 871345 |
| Date Received | 2007-06-26 |
| Date of Report | 2007-06-26 |
| Date of Event | 2007-05-01 |
| Date Added to Maude | 2007-07-10 |
| 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 |
| 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 | BREATHING INHALER |
| Product Code | KCO |
| Date Received | 2007-06-26 |
| Lot Number | 7ZP8042 |
| Device Expiration Date | 2008-07-01 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855345 |
| Manufacturer | GLAXOSMITH KLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-26 |