MAUDE report
MAUDE report 9778: ROTABLATOR
No Answer Provided · received Apr 29, 1994 · HEART TECHNOLOGY, INC.
Key facts
| MDR report key | 9778 |
|---|---|
| Report number | 9778 |
| Event type | No Answer Provided |
| Brand name | ROTABLATOR |
| Model number | 22113-5 |
| Manufacturer | HEART TECHNOLOGY, INC. |
| Product code | MKI |
| Date received by FDA | Apr 29, 1994 |
| Report date | Apr 8, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 10–99 MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- 10–99 Death reports for this brand
- 10–99 Injury reports for this brand
- 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: