MAUDE report

MAUDE report 28909: FOGARTY ARTERIAL EMBOLECTOMY CATHETER

No Answer Provided · received Aug 30, 1995 · EDWARDS LIS DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 28909
Report number 28909
Event type No Answer Provided
Brand name FOGARTY ARTERIAL EMBOLECTOMY CATHETER
Manufacturer EDWARDS LIS DIV. BAXTER HEALTHCARE CORP.
Product code DXE
Device class Class II
Date received by FDA Aug 30, 1995
Report date Jun 7, 1995
Report source Maude

At a glance

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

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