MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-08 for SILICONE IMPLANT manufactured by Unknown.
[18742]
Rptr had a solid silicone implant placed above her eyes (about 50% of her lower forehead) when she was 10 years old, 20 years ago. She had some breathing problems for about 5 years; then, starting about 1/1/95, she began suffering from extreme head pain for extended periods of time. She lost her balance and was unable to drive or read due to pain. Her nose and throat would swell until they were almost closed. She went to the er and was sent home with drops. Eventually she lost her balance and could barely walk. She is scheduled to go back to surgery in about 2 weeks. Currently, the head pain and some of the swelling have subsided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009051 |
| MDR Report Key | 32757 |
| Date Received | 1996-05-08 |
| Date of Report | 1996-05-07 |
| Date of Event | 1995-01-01 |
| Date Added to Maude | 1996-05-10 |
| 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 IMPLANT |
| Generic Name | SILICONE IMPLANT |
| Product Code | MIB |
| Date Received | 1996-05-08 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34043 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1996-05-08 |