D
Patient 1
THIS EVENT WAS REPORTED AS DEHISCENCE AND INFECTION. NO FURTHER INFO WAS PROVIDED.
MAUDE MDR 108052
- MDR report key
- 108052
- Report number
- 6000002-1997-00629
- Event key
- 0
- Event type
- 3
- Date of event
- 1997-05-06
- Date received
- 1997-07-25
- 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
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EDWARDS PERICARDIAL PATCH | PERICARDIAL PATCH | BAXTER HEALTHCARE CORP. EDWARDS CVS DIVISION | MFX | 4700 | NA | 6L1297 | K833763 | Y | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1997-07-25 | 0 | 1. R |
Event Narratives
Related GUDID Devices By Product Code
No records found.