MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-10 for BREAS VIVO 50 215000 manufactured by Breas Medical Ab.
| Report Number | 9617566-2019-00015 |
| MDR Report Key | 8681951 |
| Date Received | 2019-06-10 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-05-03 |
| Date Mfgr Received | 2019-05-07 |
| Device Manufacturer Date | 2016-03-08 |
| Date Added to Maude | 2019-06-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ELISABETH CARLSSON |
| Manufacturer Street | FORETAGSVAGEN 1 |
| Manufacturer City | MOLNLYCKE, 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal | 43533 |
| Manufacturer G1 | BREAS MEDICAL AB |
| Manufacturer Street | FORETAGSVAGEN 1 |
| Manufacturer City | MOLNLYCKE, 43533 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 43533 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREAS VIVO 50 |
| Generic Name | RESPIRATORY THERAPY DEVICE (HOMECARE USE) |
| Product Code | NOU |
| Date Received | 2019-06-10 |
| Model Number | BREAS VIVO 50 |
| Catalog Number | 215000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREAS MEDICAL AB |
| Manufacturer Address | FORETAGSVAGEN 1 MOLNLYCKE, 43533 SW 43533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-10 |