MAUDE report
MAUDE report 37383: CARPENTIER-EDWARDS BIOPROSTHESIS
Injury · received Sep 4, 1996 · EDWARDS CVS DIV. BAXTER HEALTHCARE CORP.
Key facts
| MDR report key | 37383 |
|---|---|
| Report number | 6000002-1996-00052 |
| Event type | Injury |
| Brand name | CARPENTIER-EDWARDS BIOPROSTHESIS |
| Model number | 2625 |
| Catalog number | UNK |
| Manufacturer | EDWARDS CVS DIV. BAXTER HEALTHCARE CORP. |
| Product code | LWR |
| Device class | Class III |
| Date received by FDA | Sep 4, 1996 |
| Report date | Aug 5, 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: