FDA Adverse Event
Injury
Summary report: N
CLOSURE CATHETER
MDR report key: 382542
·
Received March 15, 2002
Report
- Report Number
- 2953189-2002-00005
- Event Type
- Injury
- Date Received
- March 15, 2002
- Report Date
- March 15, 2002
- Manufacturer
- VNUS MEDICAL TECHNOLOGIES, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
POST CLOSURE PROCEDURE, A THROMBUS WAS DETECTED. THERE WAS NO MALFUNCTION OF THE DEVICE ACCORDING TO THE REPORTING PHYSICIAN. NO OTHER DETAILS ARE PROVIDED DUE TO THE CONCERNS ABOUT DISCLOSING CONFIDENTIAL PATIENT DATA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLOSURE CATHETER | INTRAVASCULAR CATHETER | GEI | VNUS MEDICAL TECHNOLOGIES, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | NO INFORMATION IS AVAILABLE. |