MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-10 for AM3 96127456 manufactured by Ert.
[19582934]
Subject started study using am3 device evening of (b)(6) 2012 and continued thru the morning of (b)(6) 2012. Subject returned device on (b)(6) 2012 stating blowing into device twice a day made her chest tighten up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025017 |
| MDR Report Key | 2536589 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-03-23 |
| Date Added to Maude | 2012-04-17 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AM3 |
| Generic Name | AM3 |
| Product Code | BZG |
| Date Received | 2012-04-10 |
| Model Number | 96127456 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-10 |