MAUDE report
MAUDE report 83416: CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
Injury · received Apr 9, 1997 · BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
Key facts
| MDR report key | 83416 |
|---|---|
| Report number | 6000002-1997-00305 |
| Event type | Injury |
| Brand name | CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING |
| Model number | 4400 |
| Manufacturer | BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. |
| Product code | KRH |
| Device class | Class II |
| Date received by FDA | Apr 9, 1997 |
| Report date | Mar 10, 1997 |
| 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
- 10–99 Death reports for this brand
- 100–999 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: