MAUDE report
MAUDE report 16012: PECOR STAT-DL INTRA-AORTIC BALLOON CATHETER
Injury · received Sep 12, 1994 · DATASCOPE CORP.
Key facts
| MDR report key | 16012 |
|---|---|
| Report number | MW1003297 |
| Event type | Injury |
| Brand name | PECOR STAT-DL INTRA-AORTIC BALLOON CATHETER |
| Model number | 0684-00-0255-04 |
| Catalog number | 0684-00-0255-04 |
| Manufacturer | DATASCOPE CORP. |
| Product code | DSP |
| Device class | Class II |
| Date received by FDA | Sep 12, 1994 |
| Report date | Aug 30, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- No 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: