MAUDE report

MAUDE report 40551: BAXTER

Injury · received Sep 27, 1996 · EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 40551
Report number 40551
Event type Injury
Brand name BAXTER
Model number 4312N
Catalog number *
Manufacturer EDWARDS CRITICAL CARE DIV. BAXTER HEALTHCARE CORP.
Product code FMG
Device class Class II
Date received by FDA Sep 27, 1996
Report date Aug 26, 1996
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
  • 10–99 Death reports for this brand
  • 100–999 Injury reports for this brand
  • No 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