MAUDE report

MAUDE report 904: GENIUS

Death · received Jun 29, 1992 · INTELLIGENT MEDICAL SYSTEMS

Key facts

MDR report key 904
Report number 32574-1992-00001
Event type Death
Brand name GENIUS
Catalog number 3000-2500
Manufacturer INTELLIGENT MEDICAL SYSTEMS
Product code FLL
Device class Class II
Date received by FDA Jun 29, 1992
Report date Jun 18, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 1–9 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