MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-21 for CO-SET KIT 93610 manufactured by Edwards Lifesciences, Llc.
| Report Number | MW5087557 |
| MDR Report Key | 8727355 |
| Date Received | 2019-06-21 |
| Date of Report | 2019-06-19 |
| Date of Event | 2019-06-14 |
| Date Added to Maude | 2019-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | CO-SET KIT |
| Generic Name | FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2019-06-21 |
| Returned To Mfg | 2019-06-18 |
| Model Number | 93610 |
| Lot Number | 61821108 - NOT CONFIRMED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES, LLC |
| Manufacturer Address | IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-21 |