MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-09-24 for CORPATH GRX SYSTEM 303 manufactured by Corindus, Inc..
Report Number | 3007822508-2019-00009 |
MDR Report Key | 9109643 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-09-24 |
Date of Report | 2019-09-24 |
Date of Event | 2019-09-16 |
Date Mfgr Received | 2019-09-16 |
Device Manufacturer Date | 2018-11-08 |
Date Added to Maude | 2019-09-24 |
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 | BIOMEDICAL ENGINEER |
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 |
Remedial Action | RP |
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 | 2019-09-24 |
Model Number | 303 |
Catalog Number | 303 |
Device Availability | N |
Device Eval'ed by Mfgr | Y |
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 | 2019-09-24 |