MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-10 for SILICONE INJECTION manufactured by Unknown.
[14894]
Rptr had silicone injections. The silicone has formed and is very hard. In 1993 her left breast was burning and causing her a great deal of pain. She has had mammograms, and, due to the silicone injections, the dr is unable to read them to determine if she has cancer. One dr has suggested a plastic surgeon operate and scrape off the silicone. One of her concern is the birth of her son, whom she conceived after the silicone injections.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005396 |
| MDR Report Key | 20207 |
| Date Received | 1995-03-10 |
| Date of Report | 1995-02-28 |
| Date of Event | 1994-01-01 |
| Date Added to Maude | 1995-03-13 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE INJECTION |
| Product Code | KGM |
| Date Received | 1995-03-10 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20094 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-10 |