MAUDE report
MAUDE report 63531: CARPENTER EDWARDS ANNULOPLASTY RING
Injury · received Jan 16, 1997 · BAXTER HEALTHCARE CORP. EDWARDS CVS DIV.
Key facts
| MDR report key | 63531 |
|---|---|
| Report number | 6000002-1997-00041 |
| Event type | Injury |
| Brand name | CARPENTER EDWARDS ANNULOPLASTY RING |
| Model number | 4400 |
| Manufacturer | BAXTER HEALTHCARE CORP. EDWARDS CVS DIV. |
| Product code | KRH |
| Device class | Class II |
| Date received by FDA | Jan 16, 1997 |
| Report date | Dec 16, 1996 |
| 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
- 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: