MAUDE report
MAUDE report 362
No Answer Provided · received Mar 27, 1992 · LUMEX, INC.
Key facts
| MDR report key | 362 |
|---|---|
| Report number | 362 |
| Event type | No Answer Provided |
| Catalog number | RED LINE 5740-45 |
| Manufacturer | LUMEX, INC. |
| Product code | FRJ |
| Device class | Class I |
| PMA or 510(k) number | Device Exempt |
| Date received by FDA | Mar 27, 1992 |
| Report date | Mar 16, 1992 |
| Report source | Maude |
At a glance
- None Device problems coded
- 100–999 MAUDE reports for this product code
- 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: