MAUDE report

MAUDE report 40948: ARROW/KONTRON 9 FR INTRA-AORTIC BALLOON

Injury · received Oct 2, 1996 · ARROW INTERNATONAL, INC.

Key facts

MDR report key 40948
Report number 1219856-1996-00005
Event type Injury
Brand name ARROW/KONTRON 9 FR INTRA-AORTIC BALLOON
Catalog number IAB-04240
Manufacturer ARROW INTERNATONAL, INC.
Product code DSP
Device class Class II
Date received by FDA Oct 2, 1996
Report date Oct 1, 1996
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
  • 1–9 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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