FDA Adverse Event
Other
Summary report: N
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
MDR report key: 2249678
·
Received August 23, 2011
Report
- Report Number
- 3003862400-2011-00006
- Event Type
- Other
- Date Received
- August 23, 2011
- Report Date
- August 23, 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
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
TWO BIOPSY SITES IN ONE PT WERE PERMANENTLY MARKED: ONE WITH A SECURMARK EVIVA 2S-13, AND ANOTHER WITH A SECURMARK EVIVA 13. PT LATER PRESENTED WITH REDNESS, SWELLING AND ITCHINESS OVER THE QUADRANT OF HER BREAST WHERE THE MARKERS WERE PACED. TIME FRAME BETWEEN MARKER PLACEMENT AND PT PRESENTATION IS UNK. IT WAS REPORTED TO HOLOGIC THAT THE PT WAS PLACED ON ANTIBIOTICS. PHYSICIAN REPORTED NO CHANGE IN SITE AFTER 24 HOURS OF TREATMENT. DEVICE IS NOT AVAILABLE FOR EVALUATION. REPEATED ATTEMPTS HAVE BEEN MADE TO GATHER FURTHER INFORMATION, BUT HOLOGIC HAS RECEIVED NO RESPONSE.
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 |