MAUDE report
MAUDE report 16007: DURAN FLEXIBLE ANNULOPLASTY RING, SIZE 29 MM
Death · received Jun 15, 1994 · MEDTRONIC HEART VALVES
Key facts
| MDR report key | 16007 |
|---|---|
| Report number | 16007 |
| Event type | Death |
| Brand name | DURAN FLEXIBLE ANNULOPLASTY RING, SIZE 29 MM |
| Model number | 601H |
| Manufacturer | MEDTRONIC HEART VALVES |
| Product code | KRH |
| Device class | Class II |
| Date received by FDA | Jun 15, 1994 |
| Report date | Jun 10, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 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: