MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-11 for TITANIUM MARKER manufactured by .
[2352534]
Titanium markers were placed in my left and right breasts after having an ultrasound guided biopsy. Soon afterward, i began experiencing sharp, piercing recurring pain where the markers were placed. The pain has become more intense over time vs. Subsiding. I did not experience any sort of breast pain prior to this procedure at (b)(6). No information was provided prior to marker placement it was orally presented at the end of my procedure as safe, non-adversarial and routine. This product has been life changing as not a day goes by that i am not in pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023102 |
| MDR Report Key | 2341631 |
| Date Received | 2011-11-11 |
| Date of Report | 2011-11-11 |
| Date of Event | 2010-10-27 |
| Date Added to Maude | 2011-11-21 |
| 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 | TITANIUM MARKER |
| Product Code | MIJ |
| Date Received | 2011-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-11-11 |