FDA Adverse Event
Other
Summary report: N
EVIVA BIOPSY SYSTEM
MDR report key: 1570987
·
Received January 5, 2010
Report
- Report Number
- 3003862400-2010-00001
- Event Type
- Other
- Date Received
- January 5, 2010
- Date of Event
- December 3, 2009
- Report Date
- January 5, 2010
- Manufacturer
- HOLOGIC, INC.
- Product Code
- KNW
- PMA / PMN Number
- K042290
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DOCTOR REPORTED THAT PATIENT WAS SENT FOR OPEN SURGICAL BIOPSY PROCEDURE DUE TO THE FACT THAT HE WAS UNABLE TO SUCCESSFULLY TARGET THE LESION FOR BIOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVIVA BIOPSY SYSTEM | VACUUM ASSISTED BREAST BIOPSY DEVICE | KNW | HOLOGIC, INC. | EVIVA 0913-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |