MAUDE report

MAUDE report 6897: SIMPSON CORONARY AATHEROCATH SCA-EX

Death · received Nov 12, 1993 · DEVICES FOR VASCULAR INTERVENTION, INC.

Key facts

MDR report key 6897
Report number 6897
Event type Death
Brand name SIMPSON CORONARY AATHEROCATH SCA-EX
Model number 7F9MM
Catalog number EX 70-09
Manufacturer DEVICES FOR VASCULAR INTERVENTION, INC.
Product code MCX
Device class Class III
Date received by FDA Nov 12, 1993
Report date Oct 15, 1993
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
  • None 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:

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