MAUDE report
MAUDE report 27328: GEL-FILLED MAMMARY IMPLANT
Injury · received Oct 20, 1995 · DOW CORNING CORP.
Key facts
| MDR report key | 27328 |
|---|---|
| Report number | MW1007397 |
| Event type | Injury |
| Brand name | GEL-FILLED MAMMARY IMPLANT |
| Model number | DOW CORNING |
| Catalog number | HM111359 LEFT,1111061125 RIGHT |
| Manufacturer | DOW CORNING CORP. |
| Product code | FTR |
| Device class | Class III |
| Date received by FDA | Oct 20, 1995 |
| Report date | Sep 12, 1995 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 100–999 MAUDE reports for this brand
- 1–9 Death reports for this brand
- 100–999 Injury reports for this brand
- Yes Adverse event flagged
- Yes 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: