MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-22 for CUSTOM SILICONE LEG IMPLANT * manufactured by Unk.
[26380]
Pt had an auto accident 9/91 with resulting leg deformity. 6/13/96-tissue expander insertion x2 rt medial and lateral calf. 7/19/96-removal of tissue expanders and insertions of custom made silicone prosthesis. 7/30/96- drainage and blistering of area. Started on keflex. 8/3/96-changed to cipro. 8/5/96-removal of infected rt leg implant without debridement of skin and sub-q tissue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009677 |
| MDR Report Key | 35853 |
| Date Received | 1996-08-22 |
| Date of Report | 1996-08-12 |
| Date Added to Maude | 1996-08-27 |
| 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 | 0 |
| 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 | CUSTOM SILICONE LEG IMPLANT |
| Generic Name | CUSTOM SILICONE LEG IMPLANT |
| Product Code | MIB |
| Date Received | 1996-08-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37279 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-08-22 |