MAUDE report
MAUDE report 16471: HEYER-SCHULTE INFLATABLE MAMMARY PROSTHESIS, 190 CC
Injury · received Sep 28, 1994 · V. MUELLER DIV. BAXTER HEALTHCARE CORP.
Key facts
| MDR report key | 16471 |
|---|---|
| Report number | MW1003529 |
| Event type | Injury |
| Brand name | HEYER-SCHULTE INFLATABLE MAMMARY PROSTHESIS, 190 CC |
| Model number | STYLE 1600 ROUND |
| Catalog number | PL350-1620 |
| Manufacturer | V. MUELLER DIV. BAXTER HEALTHCARE CORP. |
| Product code | FWM |
| Device class | Class III |
| Date received by FDA | Sep 28, 1994 |
| Report date | Sep 26, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 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: