MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2011-12-02 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fortworth/alcon Laboratories, Inc..
[2507668]
A consumer reported swelling of the face one year following injection of the product into her cheeks. She was hospitalized and treated with cortisone. She had a recurrence, an one side of her face, one year later and was treated with cortisone again. The consumer also stated that after two years "i have 'cranoumas' for six months". She visited another doctor and was told "it will pass". Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[9494239]
No formal investigation performed due to lack of lot code provided or sample received. In addition, silikon 1000 is approved only for ophthalmic use and not for cosmetic use. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2011-00122 |
| MDR Report Key | 2363154 |
| Report Source | 01,04 |
| Date Received | 2011-12-02 |
| Date of Report | 2011-11-04 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2011-11-04 |
| Date Added to Maude | 2011-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | PAUL NITSCHMANN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-16 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152440 |
| Manufacturer G1 | ALCON - FORT WORTH / ALCON LABORATORIES, INC. |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILIKON 1000 OIL |
| Generic Name | FLUID, INTRAOCULAR |
| Product Code | LWL |
| Date Received | 2011-12-02 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - FORTWORTH/ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2011-12-02 |