MAUDE report

MAUDE report 1546: COBE

Injury · received Oct 15, 1992 · COBE LABORATORIES

Key facts

MDR report key 1546
Report number 1546
Event type Injury
Brand name COBE
Model number CENTURY SYSTEM 3
Manufacturer COBE LABORATORIES
Product code FKP
Device class Class II
Date received by FDA Oct 15, 1992
Report date Oct 8, 1992
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
  • 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:

Browse all MAUDE medical device reports