MAUDE report
MAUDE report 4157: ELECTRO-SURGICAL UNIT
Injury · received Jul 20, 1992 · ASPEN LABS
Key facts
| MDR report key | 4157 |
|---|---|
| Report number | 4157 |
| Event type | Injury |
| Brand name | ELECTRO-SURGICAL UNIT |
| Model number | EXCALIBUR |
| Manufacturer | ASPEN LABS |
| Product code | BWA |
| Device class | Class II |
| Date received by FDA | Jul 20, 1992 |
| Report date | Jun 16, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- Yes Adverse event flagged
- No 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: