FDA Adverse Event
Other
Summary report: N
ATEC BIOPSY SYSTEM
MDR report key: 1637710
·
Received March 10, 2010
Report
- Report Number
- 3003862400-2010-00004
- Event Type
- Other
- Date Received
- March 10, 2010
- Date of Event
- February 2, 2010
- Report Date
- March 2, 2010
- Manufacturer
- HOLOGIC, INC.
- Product Code
- KNW
- PMA / PMN Number
- K042290
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THAT NURSE STUCK HERSELF IN THE LEFT HAND THUMB AFTER BIOPSY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATEC BIOPSY SYSTEM | VACUUM ASSISTED BIOPSY SYTSTEM | KNW | HOLOGIC, INC. | ATEC 1212-20 | 911050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |