MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-12-14 for SILIKON 1000 OIL 8065601185 manufactured by Alcon - Fort Worth/alcon Laboratories, Inc..
[2501723]
A consumer reported that after two sessions of "tissue augmentation" by a board certified dermatologist, he experienced a rash and swelling/discomfort at the site. The consumer requested that the dermatologist not be contacted, therefore; further f/u could not be conducted.
Patient Sequence No: 1, Text Type: D, B5
[9451127]
No complaint trending can be performed due to the lack of a lot code/sample being provided. No product investigation can be performed due to the lack of a lot code being provided. Add'l info was requested by phone on 11/17/2011 and 11/22/2011. A response from the consumer has not been received and at his request, the dermatologist was not contacted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2011-00125 |
| MDR Report Key | 2386724 |
| Report Source | 04 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-11-14 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-11-14 |
| Date Added to Maude | 2011-12-27 |
| 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 S. 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 | 2011-12-14 |
| 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 - 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 | 2011-12-14 |