MAUDE report

MAUDE report 66104: CRITIKON

Injury · received Dec 31, 1996 · CRITIKON, INC.

Key facts

MDR report key 66104
Report number 66104
Event type Injury
Brand name CRITIKON
Model number 3042
Catalog number CAT#3042
Manufacturer CRITIKON, INC.
Product code FOZ
Device class Class II
Date received by FDA Dec 31, 1996
Report date Jul 8, 1996
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
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • 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:

Browse all MAUDE medical device reports