MAUDE report
MAUDE report 70678: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
Injury · received Feb 18, 1997 · EDWARDS CVS DIV., BAXTER HEALTHCARE CORP.
Key facts
| MDR report key | 70678 |
|---|---|
| Report number | 6000002-1997-00159 |
| Event type | Injury |
| Brand name | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING |
| Model number | 4450 |
| Manufacturer | EDWARDS CVS DIV., BAXTER HEALTHCARE CORP. |
| Product code | KRH |
| Device class | Class II |
| Date received by FDA | Feb 18, 1997 |
| Report date | Jan 23, 1997 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 1,000+ MAUDE reports for this brand
- 100–999 Death reports for this brand
- 1,000+ 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: