MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-13 for METAL MARKER manufactured by .
[22094394]
My doctor inserted a marker in my breast after a stereotactic breast biopsy. I have had intense itching and pain at the site and i think the marker has moved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019791 |
| MDR Report Key | 2021684 |
| Date Received | 2011-03-13 |
| Date of Report | 2011-03-13 |
| Date of Event | 2010-08-01 |
| Date Added to Maude | 2011-03-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | METAL MARKER |
| Product Code | MIJ |
| Date Received | 2011-03-13 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-13 |