FDA Adverse Event
Other
Summary report: N
ATEC BREAST BIOPSY AND EXCISION SYSTEM
MDR report key: 2214008
·
Received August 1, 2011
Report
- Report Number
- 3003862400-2011-00005
- Event Type
- Other
- Date Received
- August 1, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 1, 2011
- Manufacturer
- HOLOGIC, INC.
- Product Code
- KNW
- PMA / PMN Number
- K042290
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS EVALUATED BY MFR AND NO TISSUE FILTER WAS PRESENT AT THAT TIME. IT CANNOT BE CONFIRMED WITH CERTAINTY THAT THE TISSUE FILTER WAS NOT PRESENT AT THE TIME IT WAS REC'D BY THE CUSTOMER.
Description of Event or Problem · 1
AN ATEC 1212-20 BIOPSY DEVICE WAS ALLEGEDLY DELIVERED W/O A TISSUE FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATEC BREAST BIOPSY AND EXCISION SYSTEM | KNW - INSTRUMENT, BIOPSY | KNW | HOLOGIC, INC. | ATEC 1212-20 | 104069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |