MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-04 for RETROGRADE CARDIOPLEGIA CATHETER RC2012 manufactured by Edwards Lifesciences.
| Report Number | 3008500478-2020-00190 |
| MDR Report Key | 9787727 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-04 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-11-21 |
| Date Added to Maude | 2020-03-04 |
| 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 | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | 1 EDWARDS WAY MLE-2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETROGRADE CARDIOPLEGIA CATHETER |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2020-01-13 |
| Model Number | RC2012 |
| Catalog Number | RC2012 |
| Lot Number | 62664287 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |