FDA Adverse Event
Other
Summary report: N
TRIMARK TRAPDOOR 36-09 DEVICE
MDR report key: 922587
·
Received October 3, 2007
Report
- Report Number
- 3003862400-2007-00008
- Event Type
- Other
- Date Received
- October 3, 2007
- Date of Event
- September 5, 2007
- Report Date
- October 3, 2007
- Manufacturer
- HOLOGIC, INC. - SUROS DIVISION
- Product Code
- NEU
- PMA / PMN Number
- K023450
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ISSUE EXPERIENCED BY USER IS CONSISTENT WITH FAILURE TO FOLLOW INSTRUCTIONS FOR USE (IFU).
Description of Event or Problem · 1
FACILLITY USED THE ATEC TRIMARK TRAPDOOR (TD) 36-09 MARKER TO MARK THE SITE OF A BIOPSY. THIS PRODUT IS USED IN CONJUNCTION WITH THE ATEC 9 GAUGE HANDPIECES. DISCUSSION WITH FACILITY STAFF IDENTIFIED THAT PART OF THE TRIMARK TD DEVICE HAD BEEN DETACHED AND LEFT BEHIND AT THE BIOPSY SITE IN POST PROCEDURE IMAGES. IT WAS COMMUNICATED TO SUROS THAT THE ACCOUNT DOES NOT TYPICALLY USE THE ALIGNMENT GUIDE LISTED IN THE INSTRUCTIONS FOR USE (IFU).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIMARK TRAPDOOR 36-09 DEVICE | BIOPSY SITE TISSUE MARKER DEVICE | NEU | HOLOGIC, INC. - SUROS DIVISION | TRIMARK TD 36-09 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |