MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-17 for AMERICAN EDWARDS DUROMEDICS 9120 manufactured by American Edwards.
[10165]
Patient came into the hospital with acute prosthetic mitral valve insufficiency due to defective mitral valve. One leaflet missing from the mechanical valve. Mitral valve prosthesis replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18773 |
| MDR Report Key | 18773 |
| Date Received | 1994-11-17 |
| Date of Report | 1994-10-21 |
| Date of Event | 1994-10-14 |
| Date Facility Aware | 1994-10-14 |
| Report Date | 1994-10-21 |
| Date Added to Maude | 1995-01-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMERICAN EDWARDS DUROMEDICS |
| Generic Name | 31 MM MITRAL VALVE PROSTHESIS |
| Product Code | MIM |
| Date Received | 1994-11-17 |
| Model Number | 9120 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 18701 |
| Manufacturer | AMERICAN EDWARDS |
| Manufacturer Address | P.O. BOX 11150 SANTA ANNA CA 927111150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-11-17 |