D
Patient 1
HEALTH CARE PROFESSIONAL REPORTED PERICARDIAL PATCH WAS ABANDONED DUE TO WHITE MATERIAL FLOATING IN THE JAR. THE PATCH WAS NEVER USED FOR IMPLANT PURPOSES - NO PT CONSEQUENCES WERE REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.
MAUDE MDR 166232
- MDR report key
- 166232
- Report number
- 2025587-1998-00018
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-04-01
- Date received
- 1998-05-01
- 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
- 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 - 5 CM X 12 CM | BOVINE PERICARDIAL PATCH | MEDTRONIC HEART VALVES, INC. | MFX | 710 | HP710 | NA | K830883 | N | Y | R |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-05-01 | 0 | 1. O |
Event Narratives
Related GUDID Devices By Product Code
No records found.