FDA Adverse Event
Other
Summary report: N
SECURMARK FOR ATEC
MDR report key: 1911544
·
Received November 23, 2010
Report
- Report Number
- 3003862400-2010-00009
- Event Type
- Other
- Date Received
- November 23, 2010
- Report Date
- November 22, 2010
- Manufacturer
- HOLOGIC, INC.
- Product Code
- NEU
- PMA / PMN Number
- K072913
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AS REPORTED: A CUSTOMER USES THE (B)(4) WITH THE(B)(4) ON A GE UPRIGHT SYSTEM. WHEN THEY TURNED THE NEEDLE THEY CUT OFF A PIECE OF PLASTIC OF THE MARKER NEEDLE LEAVING IT BEHIND IN THE PT'S BREAST. THE PIECE WAS SURGICALLY REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURMARK FOR ATEC | BIOPSY SITE TISSUE MARKER | NEU | HOLOGIC, INC. | SMARK-ATEC-2S-36-09 | 1002016A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |