FDA Adverse Event
Injury
Summary report: N
HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT
MDR report key: 141602
·
Received January 5, 1998
Report
- Report Number
- 6000072-1997-00031
- Event Type
- Injury
- Date Received
- January 5, 1998
- Date of Event
- April 10, 1997
- Report Date
- December 9, 1997
- Manufacturer
- MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
- Product Code
- MAL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE GRAFT WAS IMPLANTED ON 4/1/97 AS A BILATERAL FEMORAL POPLITEAL BYPASS GRAFT. THERE WERE NO COMPLICATIONS AND THE PT WAS SUBSEQUENTLY DISCHARGED WITHOUT A PROBLEM. ON 4/10/97, THE PT COMPLAINED OF DISCOMFORT. ON EXAMINATION, ALTHOUGH THE PT HAD NO FEVER, INFLAMMATORY FLUID CONTAINING WHITE CELLS, WAS FOUND TO BE ACCUMULATING AROUND THE GRAFT. CULTURES WERE NEGATIVE. THE GRAFT REMAINS IMPLANTED. THE PT IS STILL EXPERIENCING DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant | SEALED VASCULAR GRAFT | MAL | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. | 085168 | 166040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |