MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-23 for CORPATH GRX SYSTEM 305 manufactured by Corindus, Inc..
| Report Number | 3007822508-2019-00008 |
| MDR Report Key | 9106417 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-23 |
| Date of Report | 2019-09-23 |
| Date of Event | 2019-09-11 |
| Date Mfgr Received | 2019-09-16 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2019-09-23 |
| 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 | MR. ROBERT LAVADO |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | 5086533335 |
| Manufacturer G1 | CORINDUS, INC. |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02452 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPATH GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2019-09-23 |
| Model Number | 305 |
| Catalog Number | 305 |
| Lot Number | 10H2019 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORINDUS, INC. |
| Manufacturer Address | 309 WAVERLEY OAKS ROAD SUITE 105 WALTHAM MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-23 |