FDA Adverse Event
Summary report: N
VASCUTEK
MDR report key: 1981705
·
Received January 30, 2011
Report
- Report Number
- 1981705
- Date Received
- January 30, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 30, 2011
- Manufacturer
- TERUMO
- Product Code
- DSY
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PHYSICIAN NOTED A SMALL GLOB (APPROX. SIZE OF A PEA) OF CLEAR PALE YELLOW MATERIAL ADHERED TO THE INSIDE OF THE GRAFT. THIS PORTION OF THE GRAFT WAS NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASCUTEK | PROSTHESIS, VASCULAR GRAFT | DSY | TERUMO | 733024 | 111802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |