MAUDE report
MAUDE report 78452: COBE SPECTRA APHERESIS SYSTEM
Injury · received Mar 21, 1997 · COBE BCT, INC.
Key facts
| MDR report key | 78452 |
|---|---|
| Report number | 1721028-1997-00003 |
| Event type | Injury |
| Brand name | COBE SPECTRA APHERESIS SYSTEM |
| Catalog number | 950000-000 |
| Manufacturer | COBE BCT, INC. |
| Product code | LKN |
| Device class | Unclassified |
| Date received by FDA | Mar 21, 1997 |
| Report date | Mar 19, 1997 |
| Report source | Maude |
At a glance
- None Device problems coded
- 1,000+ MAUDE reports for this product code
- 10–99 MAUDE reports for this brand
- 1–9 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: