FDA Adverse Event
Other
Summary report: N
SHELHIGH PERICARDIAL PATCH
MDR report key: 286027
·
Received July 12, 2000
Report
- Report Number
- 2247123-2000-00002
- Event Type
- Other
- Date Received
- July 12, 2000
- Report Date
- July 11, 2000
- Manufacturer
- SHELHIGH, INC.
- Product Code
- MFX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHELHIGH PERICARDIAL PATCH | BOVINE PERICARDIAL PATCH | MFX | SHELHIGH, INC. | NRSHP555 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |