MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-09-13 for SILASTIC MAMMARY IMPLANT UNK manufactured by Dow Corning Corp..
[20821]
Pt received breast implants on an unk date and of an unk mfr. Pt is very nervous.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1816403-1996-00056 |
| MDR Report Key | 38407 |
| Report Source | 00 |
| Date Received | 1996-09-13 |
| Date of Report | 1996-08-15 |
| Date Mfgr Received | 1996-08-15 |
| Date Added to Maude | 1996-09-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILASTIC MAMMARY IMPLANT |
| Generic Name | MAMMARY IMPLANT, GEL-FILLED |
| Product Code | FRT |
| Date Received | 1996-09-13 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 39659 |
| Manufacturer | DOW CORNING CORP. |
| Manufacturer Address | 2200 WEST SALZBURG RD AUBURN MI 48611 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-13 |