MAUDE report
MAUDE report 65050: SYSTEM 1000 SPDS
Other · received Jan 23, 1997 · ALTHIN MED, INC. PORTLAND SITE
Key facts
| MDR report key | 65050 |
|---|---|
| Report number | 3019627-1997-00005 |
| Event type | Other |
| Brand name | SYSTEM 1000 SPDS |
| Model number | SYSTEM 1000 |
| Manufacturer | ALTHIN MED, INC. PORTLAND SITE |
| Product code | FKP |
| Device class | Class II |
| Date received by FDA | Jan 23, 1997 |
| Report date | Jan 22, 1997 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 100–999 MAUDE reports for this brand
- 10–99 Death reports for this brand
- 10–99 Injury reports for this brand
- 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: