MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-01 for EMPOWER CTA + manufactured by Bracco Injeneering S.a..
| Report Number | 3004753774-2019-00004 |
| MDR Report Key | 9140039 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-01 |
| Date of Report | 2019-09-06 |
| Report Date | 2019-09-06 |
| Date Reported to Mfgr | 2019-09-06 |
| Date Mfgr Received | 2019-09-06 |
| Date Added to Maude | 2019-10-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CEDRIC BOESCH |
| Manufacturer Street | 46 AVENUE SEVELIN |
| Manufacturer City | SEVELIN, LAUSANNE CH-10004 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-10004 |
| Manufacturer G1 | BRACCO INJENEERING SA |
| Manufacturer Street | 46 AVENUE SEVELIN |
| Manufacturer City | SEVELIN, CH-10004 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-10004 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMPOWER CTA + |
| Generic Name | EMPOWER CTA + |
| Product Code | IZQ |
| Date Received | 2019-10-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING S.A. |
| Manufacturer Address | 46 AVENUE SEVELIN LAUSANNE, CH-1004 SZ CH-1004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-10-01 |