MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-22 for CUSTOM MADE SILICONE CHEST IMPLANT * manufactured by Unk.
[23682]
4/20/95-chest wall reconstruction with custom silicone implant. 5/19/95-revision of chest wall implant. 8/9/96-removal of infected chest wall implant with associated capsulectomy. Apparently pt fell and dislodged implant with subsequent infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009785 |
| MDR Report Key | 35854 |
| 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 MADE SILICONE CHEST IMPLANT |
| Generic Name | PECTUS IMPLANT |
| Product Code | MIC |
| Date Received | 1996-08-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 37280 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-08-22 | |
| 2 | 0 | 1996-08-22 |