MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-24 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 manufactured by Atricure, Inc..
| Report Number | 3011706110-2019-00031 |
| MDR Report Key | 8726828 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-24 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2019-05-29 |
| Date Added to Maude | 2019-06-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
| Generic Name | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
| Product Code | OCL |
| Date Received | 2019-06-24 |
| Model Number | CDK-1413 |
| Catalog Number | CDK-1413 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-06-24 |