MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2010-08-27 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth/ Alcon Laboratories, Inc..
[1354885]
Adverse event(s): "two lumps on right cheek" (no code available). Product problem(s): "off label use" (use of device issue). A consumer reported "two lumps on right cheek" during use of this product for dermatologic purpose as treatment for facial scarring (off-label use). She stated that treatment began about a year ago with another product (triamcinolone), having done "four rounds" every two weeks, and that it was "working too slow". Her doctor started treatment with this product and she was unsure if this product was given as treatment and/or to fill in the indentations created by the triamcinolone. She stated the treatments were done in an office setting and she was aware that use of this product for dermatologic purpose is off-label. In a follow-up with the doctor, he stated that the pt's "lumps are barely perceptible" and that she continues to seek other treatment options. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[8722018]
The product was not returned for analysis. Product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the mfg documentation. The report indicated off-label use of product. Additional info was requested on 07/30/2010 and 08/05/2010 by phone, fax, and mail. Additional info was obtained by phone. A completed questionnaire has not been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2010-00105 |
| MDR Report Key | 1821687 |
| Report Source | 04,05 |
| Date Received | 2010-08-27 |
| Date of Report | 2010-07-29 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-07-29 |
| Date Added to Maude | 2010-12-28 |
| 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 | CHARLES DOLBEE |
| Manufacturer Street | 6201 SOUTH FREEWAY, R7-18 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175518317 |
| 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 | 2010-08-27 |
| Model Number | NA |
| Catalog Number | 8065601185 |
| Lot Number | NI |
| 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 - FORT WORTH/ ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-27 |