MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for SILIKON 1000 (LIPO-DYSHOPY) * manufactured by Alcon.
[347577]
Pt seeing do, for facial wasting. However, another do came to give pt treatment of silikon 1000 (injectables). Pt said that doctor told them that it was not fda approved. Pt said that they became sick (fatigue) for 3 days afterward (but no nausea or fever); used ice packs to put on face. Said that there was no improvement in face-cheeks were not fuller. Pt had 75 tiny injections on each side of face. 1st gave novacaine. Product was intended for ophthalmic rinse; doctor had used it for off-label use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003868 |
| MDR Report Key | 570540 |
| Date Received | 2005-02-02 |
| Date of Report | 2005-01-14 |
| Date of Event | 2005-01-09 |
| Date Added to Maude | 2005-02-08 |
| 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 |
| 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 | SILIKON 1000 (LIPO-DYSHOPY) |
| Generic Name | LIQUID SILICON INJECTABLE |
| Product Code | KGM |
| Date Received | 2005-02-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | PHP-09-02 |
| ID Number | * |
| Device Expiration Date | 2006-05-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 560388 |
| Manufacturer | ALCON |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-02 |