MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-03 for MCGHAN STYLE 120 MCGHAN 600CC manufactured by Mcghan/inamed Corp..
[16835502]
Infected bilateral breast implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042819 |
| MDR Report Key | 850552 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-05-03 |
| Date of Event | 2007-03-20 |
| Date Added to Maude | 2007-05-16 |
| 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 | RISK MANAGER |
| 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 | MCGHAN |
| Generic Name | BREAST IMPLANTS |
| Product Code | FTR |
| Date Received | 2007-05-03 |
| Model Number | STYLE 120 |
| Catalog Number | MCGHAN 600CC |
| Lot Number | LEFT 1310356 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 837484 |
| Manufacturer | MCGHAN/INAMED CORP. |
| Manufacturer Address | 700 WARD DRIVE SANTA BARBARA CA 93111 US |
| Brand Name | MCGHAN |
| Generic Name | BREAST IMPLANTS |
| Product Code | FWW |
| Date Received | 2007-05-03 |
| Model Number | STYLE 120 |
| Catalog Number | MCGHAN 600CC |
| Lot Number | RIGHT |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 837485 |
| Manufacturer | MCGHAN/INAMED CORP. |
| Manufacturer Address | 700 WARD DRIVE SANTA BARBARA CA 93111 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-03 |