MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-21 for OPTI16 manufactured by Edwards Life Sciences.
| Report Number | 8739261 |
| MDR Report Key | 8739261 |
| Date Received | 2019-06-21 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-05-31 |
| Report Date | 2019-06-14 |
| Date Reported to FDA | 2019-06-14 |
| Date Added to Maude | 2019-06-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTI16 |
| Generic Name | OPTI SITE CANNULA, 16 FRENCH |
| Product Code | DQR |
| Date Received | 2019-06-21 |
| Lot Number | 61800856 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFE SCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-06-21 |