FDA Adverse Event
Other
Summary report: N
BOOMERANG 610
MDR report key: 822554
·
Received February 20, 2007
Report
- Report Number
- 3004182619-2007-00004
- Event Type
- Other
- Date Received
- February 20, 2007
- Date of Event
- November 28, 2006
- Report Date
- February 20, 2007
- Manufacturer
- CARDIVA MEDICAL, INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PERIPHERAL INTERVENTION, 7 FR SHEATH, ANGIOMAX AND INTEGRILIN DRIP. HEMATOMA WAS EXPRESSED AND A FEMOSTOP WAS APPLIED FOR 4 HOURS. HEMATOMA SIZE - 4 INCHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BOOMERANG 610 | VASCULAR CLOSURE DEVICE | MGB | CARDIVA MEDICAL, INC. | BOOMERANG 610 | 610061002A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |