MAUDE MDR 993100
- MDR report key
- 993100
- Report number
- 6000002-2008-06001
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-04-04
- 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 MAILSTOP: PRT46 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 APPROXIMATELY AFTER AN IMPLANT DURATION OF 4.3 MONTHS (IN 2007, AFTER AN IMPLANT APPROXIMATELY 4 MONTHS BEFORE ), DUE TO UNKNOWN REASONS. UNK IF PT DEATH IS DEVICE RELATED. 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 |