D
Patient 1
HEALTHCARE PROFESSIONAL REPORTED THAT THE PERICARDIAL PATCH WAS USED ON PT FOR A DURA PATCH. ONE WEEK LATER PT HAD AN INFLAMATORY REACTION AND DEVELOPED SIGNS OF HYDROCEPHALUS. RECOVERED AFTER 4 WEEK TREATMENT WITH STEROIDS.
MAUDE MDR 288680
- MDR report key
- 288680
- Report number
- 2025587-2000-00060
- Event key
- 0
- Event type
- 3
- Date of event
- 2000-04-12
- Date received
- 2000-08-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Related Records
Manufacturer Contact
- Contact
- KATHRYN LYNESS
- Address
- 7000 CENTRAL AVENUE N.E. MINNEAPOLIS MN 55440 US
- Phone
- 763-763-7635
- 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 | S00846001I | K830883 | Y | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-08-04 | 0 | 1. R |
Event Narratives
Related GUDID Devices By Product Code
No records found.