MAUDE report
MAUDE report 38842: GEL-FILLED MAMMARY PROSTHESIS
Injury · received Sep 20, 1996 · BAXTER-SURGICAL GROUP
Key facts
| MDR report key | 38842 |
|---|---|
| Report number | 42933-1996-00058 |
| Event type | Injury |
| Brand name | GEL-FILLED MAMMARY PROSTHESIS |
| Model number | 350-6175 |
| Catalog number | 350-6175 |
| Manufacturer | BAXTER-SURGICAL GROUP |
| Product code | FTR |
| Device class | Class III |
| Date received by FDA | Sep 20, 1996 |
| Report date | Sep 20, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- Yes Adverse event flagged
- No Product problem flagged
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE medical device reports
MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.
Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date: