MAUDE MDR 286027
- MDR report key
- 286027
- Report number
- 2247123-2000-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 1969-12-31
- Date received
- 2000-07-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact
- Address
- 67-71 E WILLOW ST MILLBURN NJ 07041 US
- Phone
- 973-973-9734
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | SHELHIGH PERICARDIAL PATCH | BOVINE PERICARDIAL PATCH | SHELHIGH, INC. | MFX | NRSHP555 | NRSHP555 | * | | | N | Y | Y |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2000-07-12 | 0 | 1. H
|
Event Narratives
D
Patient 1
MEDIASTINITIS POST OPEN HEART SURGERY. THE SHELHIGH PERICARDIAL PATCH WAS USED AS A PERICARDIAL SUBSTITUTE. EIGHT (8) CASES OF MEDIASTINITIS OCCURRED IN ONE HOSP IN GERMANY. THIS INFECTION IS A WELL KNOWN COMPLICATION AFTER OPEN HEART SURGERY.
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 |