MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-11 for LIQUID INJECTABLE SILICONE manufactured by Na.
[995351]
Pt had "medical grade" liquid injectable silicone injected by a nyc dermatologist for improvement of wrinkles into glabella and nasolabial folds 15 years ago. Has now developed nodules which have been biopsied and diagnosed as silicone granulomas. Largest has been 5cm in diameter. They wax and wane in their size, are painful and are disfiguring. Dose or amoung:? ; frequency: twice; route: id. Dates of use: 2 mos; diagnosis or reason for use: wrinkle correction;
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008957 |
| MDR Report Key | 1227035 |
| Date Received | 2008-11-11 |
| Date of Report | 2008-11-11 |
| Date Added to Maude | 2008-11-20 |
| 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 |
| 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 | LIQUID INJECTABLE SILICONE |
| Product Code | KGM |
| Date Received | 2008-11-11 |
| Model Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1283421 |
| Manufacturer | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-11-11 |