MAUDE report
MAUDE report 4284: PRELOAD 56CC 10.57V PERCOR STAT DL, DISPOSABLE
Malfunction · received Jul 16, 1992 · DATASCOPE
Key facts
| MDR report key | 4284 |
|---|---|
| Report number | 4284 |
| Event type | Malfunction |
| Brand name | PRELOAD 56CC 10.57V PERCOR STAT DL, DISPOSABLE |
| Manufacturer | DATASCOPE |
| Product code | KFM |
| Device class | Class II |
| Date received by FDA | Jul 16, 1992 |
| Report date | Jul 16, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 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: