MAUDE MDR 993107
- MDR report key
- 993107
- Report number
- 6000002-2008-05999
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-10-01
- Date received
- 2008-02-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
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 | BOVINE PERICARDIAL PATCH | PERICARDIAL PATCH | EDWARDS LIFESCIENCES | MFX | 4700 | NA | UNK | | | Y | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2008-02-06 | 0 | 1. D
|
Event Narratives
D
Patient 1
REPORTEDLY, PT EXPIRED AFTER AN IMPLANT IN 2006 DUE TO UNK REASONS. UNK IF PT DEATH IS DEVICE RELATED. DATE OF PT'S DEATH AND IMPLANT DURATION IS UNK, THEREFORE, THE AWARE DATE IS USED AS THE OCCURRENCE DATE. NO FURTHER INFO REGARDING THIS PT WAS RECEIVED.
N
Patient 1
DEVICE NOT RETURNED.
Related GUDID Devices By Product Code
No records found.
Related PMN/PMA Records By Product Code
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|
| 510(k) | K061727 | MFX | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | 2006-08-07 |
| 510(k) | K960532 | MFX | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | 1996-05-23 |