MAUDE report
MAUDE report 50516: 940 INTRA-AORTIC BALLOON CATHETER
Malfunction · received Nov 14, 1996 · CARDIAC ASSIST A DIV OF BOSTON SCIENTIFIC CORP.
Key facts
| MDR report key | 50516 |
|---|---|
| Report number | 1220076-1996-00017 |
| Event type | Malfunction |
| Brand name | 940 INTRA-AORTIC BALLOON CATHETER |
| Catalog number | 3802 |
| Manufacturer | CARDIAC ASSIST A DIV OF BOSTON SCIENTIFIC CORP. |
| Product code | GAL |
| Device class | Class II |
| Date received by FDA | Nov 14, 1996 |
| Report date | Oct 22, 1996 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- 1–9 Death reports for this brand
- None Injury reports for this brand
- 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: