FDA Adverse Event
Other
Summary report: N
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
MDR report key: 2093868
·
Received April 22, 2011
Report
- Report Number
- 3003862400-2011-00003
- Event Type
- Other
- Date Received
- April 22, 2011
- Report Date
- April 21, 2011
- Manufacturer
- HOLOGIC, INC.
- Product Code
- NEU
- PMA / PMN Number
- K062528
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT PRESENTED WITH A "SEVERE POST INFLAMMATION REACTION" TO A CLIP PLACED (B)(6) WEEKS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM | BIOPSY SITE TISSUE MARKER | NEU | HOLOGIC, INC. | SMARK-EVIVA-13 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |