D
Patient 1
REPORTEDLY PT EXPIRED AFTER AN IMPLANT IN 2004 DUE TO UNK REASONS.
MAUDE MDR 1039162
- MDR report key
- 1039162
- Report number
- 6000002-2008-06973
- Event key
- 0
- Event type
- 3
- Date of event
- 1969-12-31
- Date received
- 2008-05-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Related Records
Manufacturer Contact
- Contact
- JODI TURPIN
- Address
- ONE EDWARDS WAY IRVINE CA 92614 US
- Phone
- 949-949-9492
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PERICARDIAL PATCH | PERICARDIAL PATCH | EDWARDS LIFESCIENCES | MFX | 4700 | NA | UNK | Y | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-05-05 | 0 | 1. D |
Event Narratives
N
Patient 1
DEVICE NOT RETURNED.
Related GUDID Devices By Product Code
No records found.