MAUDE report

MAUDE report 13197: SLEEK

Injury · received May 13, 1994 · CORDIS CORP.

Key facts

MDR report key 13197
Report number 13197
Event type Injury
Brand name SLEEK
Catalog number 531-4254
Manufacturer CORDIS CORP.
Product code LOX
Device class Class II
Date received by FDA May 13, 1994
Report date Feb 28, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 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:

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