MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-16 for LIQUIDE SILICON manufactured by Dow Corning Corp..
[16795499]
Rptr was treated with liquid silicone infections. Rptr was not told by the physician that this product is not approved by the fda for injection into human beings. Rptr had about 15 sessions from 10/88 to 2/90. Rptr is presently suffering from a permanent injury in his nose, causing him pain and suffering. He will need surgery to retrieve the silicone tissues according to another doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005933 |
| MDR Report Key | 21814 |
| Date Received | 1995-05-16 |
| Date of Report | 1995-04-26 |
| Date Added to Maude | 1995-05-18 |
| 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 | LIQUIDE SILICON |
| Generic Name | SILICON |
| Product Code | KGM |
| Date Received | 1995-05-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21874 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | MIDLAND MI 48686 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other; 3. Required No Informationntervention | 1995-05-16 |