FDA Adverse Event
Other
Summary report: N
GELSOFT PLUS
MDR report key: 504194
·
Received December 22, 2003
Report
- Report Number
- 9612515-2003-00019
- Event Type
- Other
- Date Received
- December 22, 2003
- Report Date
- December 22, 2003
- Manufacturer
- VASCUTEK LTD.
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GELSOFT PLUS | VASCULAR PROSTHESIS | DSY | VASCUTEK LTD. | NA | 53083/0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |