MAUDE report
MAUDE report 14275: PERCUTANEOUS SHEATH INTRODUCER KIT
Injury · received Apr 13, 1994 · ARROW INTL., INC.
Key facts
| MDR report key | 14275 |
|---|---|
| Report number | 14275 |
| Event type | Injury |
| Brand name | PERCUTANEOUS SHEATH INTRODUCER KIT |
| Model number | AK-09800 |
| Manufacturer | ARROW INTL., INC. |
| Product code | DYB |
| Device class | Class II |
| Date received by FDA | Apr 13, 1994 |
| Report date | Apr 12, 1994 |
| Report source | Maude |
At a glance
- None Device problems coded
- 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: