MAUDE report
MAUDE report 15419: HEMAFLEX PTCA SHEATH KIT
Injury · received Jan 10, 1994 · BARD, INCORPORATED
Key facts
| MDR report key | 15419 |
|---|---|
| Report number | 15419 |
| Event type | Injury |
| Brand name | HEMAFLEX PTCA SHEATH KIT |
| Catalog number | 010047 |
| Manufacturer | BARD, INCORPORATED |
| Product code | EYT |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Jan 10, 1994 |
| Report date | Dec 22, 1993 |
| Report source | Maude |
At a glance
- None Device problems coded
- 10–99 MAUDE reports for this product code
- 1–9 MAUDE reports for this brand
- None Death reports for this brand
- 1–9 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: