MAUDE report
MAUDE report 16009: RECONSTRUCTIVE BREAST IMPLANT
Other · received Jun 4, 1994 · MCGHAN MEDICAL CORP.
Key facts
| MDR report key | 16009 |
|---|---|
| Report number | 16009 |
| Event type | Other |
| Brand name | RECONSTRUCTIVE BREAST IMPLANT |
| Model number | STYLE 58 460/500 |
| Catalog number | 25-56461 |
| Manufacturer | MCGHAN MEDICAL CORP. |
| Product code | FTR |
| Device class | Class III |
| Date received by FDA | Jun 4, 1994 |
| Report date | Jun 3, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 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: