MAUDE report

MAUDE report 1201: JELCO

Injury · received Aug 25, 1992 · CRITIKON

Key facts

MDR report key 1201
Report number 1201
Event type Injury
Brand name JELCO
Model number 14-MOD
Catalog number CT-4065
Manufacturer CRITIKON
Product code FOZ
Device class Class II
Date received by FDA Aug 25, 1992
Report date Aug 10, 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
  • None 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