MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-03 for SOFT TISSUE UNK manufactured by Unk.
[508554]
Pt was injected with liquid silicone to the right side of the face, which is not approved by fda. Pt now has silicone granuloma, infection, hospitalized for 5 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036206 |
| MDR Report Key | 748762 |
| Date Received | 2005-08-03 |
| Date of Report | 2005-08-03 |
| Date of Event | 1998-01-01 |
| Date Added to Maude | 2006-08-16 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT TISSUE |
| Generic Name | LIQUID SILICONE |
| Product Code | KGM |
| Date Received | 2005-08-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 736542 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2005-08-03 |