D
Patient 1
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.
MAUDE MDR 18773
- MDR report key
- 18773
- Report number
- 18773
- Event key
- 0
- Event type
- 3
- Date of event
- 1994-10-14
- Date received
- 1994-11-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AMERICAN EDWARDS DUROMEDICS | 31 MM MITRAL VALVE PROSTHESIS | AMERICAN EDWARDS | MIM | 9120 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1994-11-17 | 0 | 1. H |