MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-02-16 for TITANIUM BREAST BIOPSY MARKER manufactured by .
[1839345]
I had a small titanium clip put in my breast as marker after a benign biopsy. The pain at the site has increased every day, now radiating to my shoulder and back, although, there is no infection at the insertion site. I am planning to ask to have the titanium clip removed immediately. I do not believe these should be used routinely. I now face more disfigurement and chance of infection for something i questioned heavily in the beginning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019456 |
| MDR Report Key | 1998784 |
| Date Received | 2011-02-16 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-02-11 |
| Date Added to Maude | 2011-02-25 |
| 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 | 3 |
| 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 |
| Brand Name | TITANIUM BREAST BIOPSY MARKER |
| Generic Name | TITANIUM BREAST BIOPSY MARKER |
| Product Code | MIJ |
| Date Received | 2011-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-16 |