MAUDE report
MAUDE report 817: CARPENTIER EDWARDS AORTIC VALVE
Death · received Jun 26, 1992 · BAXTER EDWARDS
Key facts
| MDR report key | 817 |
|---|---|
| Report number | 817 |
| Event type | Death |
| Brand name | CARPENTIER EDWARDS AORTIC VALVE |
| Model number | CL 3242 2625 21M |
| Manufacturer | BAXTER EDWARDS |
| Product code | LWQ |
| Device class | Class III |
| Date received by FDA | Jun 26, 1992 |
| Report date | Jun 8, 1992 |
| 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
- 1–9 Death reports for this brand
- None Injury reports for this brand
- 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: