MAUDE report

MAUDE report 1533: ARROW

Injury · received Oct 5, 1992 · ARROW INTERNATIONAL, INC.

Key facts

MDR report key 1533
Report number 1533
Event type Injury
Brand name ARROW
Model number RA-04020
Catalog number RA-04020
Manufacturer ARROW INTERNATIONAL, INC.
Product code FCM
Device class Class II
Date received by FDA Oct 5, 1992
Report date Sep 16, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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
  • 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