MAUDE report
MAUDE report 80302: MEDTRONIC HANCOCK AORTIC HEART PROSTHESIS
Death · received Mar 27, 1997 · MEDTRONIC CARDIAC SURGERY MEDTRONIC HEART VALVES
Key facts
| MDR report key | 80302 |
|---|---|
| Report number | 80302 |
| Event type | Death |
| Brand name | MEDTRONIC HANCOCK AORTIC HEART PROSTHESIS |
| Model number | 250D |
| Catalog number | UNK |
| Manufacturer | MEDTRONIC CARDIAC SURGERY MEDTRONIC HEART VALVES |
| Product code | DYE |
| Device class | Class III |
| Date received by FDA | Mar 27, 1997 |
| Report date | Mar 26, 1997 |
| 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
- 1–9 Death reports for this brand
- None Injury reports for this brand
- Yes Adverse event flagged
- Yes 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: