FDA Adverse Event
Injury
Summary report: N
CARDIOSEAL CS-28-QL-PFO
MDR report key: 380919
·
Received March 8, 2002
Report
- Report Number
- 1222632-2002-00008
- Event Type
- Injury
- Date Received
- March 8, 2002
- Date of Event
- February 5, 2002
- Report Date
- March 8, 2002
- Manufacturer
- NMT MEDICAL, INC.
- Product Code
- MLV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THROMBUS PT IS CURRENTLY BEING TREATED WITH HEPARIN AND COUMADIN.
Description of Event or Problem · 1
PT WITH AN NMT DEVICE DEVELOPED A THROMBUS ON THE DEVICE. PT HAS BEEN PLACED ON A REGIMENT OF HEPARIN AND COUMADIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOSEAL CS-28-QL-PFO | CARDIOSEAL | MLV | NMT MEDICAL, INC. | NI | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |