MAUDE report
MAUDE report 4063
Malfunction · received Jul 22, 1992 · BJORK - SHILEY
Key facts
| MDR report key | 4063 |
|---|---|
| Report number | 4063 |
| Event type | Malfunction |
| Model number | NI |
| Catalog number | NI |
| Manufacturer | BJORK - SHILEY |
| Date received by FDA | Jul 22, 1992 |
| Report date | Jul 17, 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: