MAUDE report

MAUDE report 34669: INTRA-AORTIC BALLOON CATHETER

Injury · received Jul 29, 1996 · DATASCOPE CORP.

Key facts

MDR report key 34669
Report number MW1009588
Event type Injury
Brand name INTRA-AORTIC BALLOON CATHETER
Model number 9.5 FR 34CC DSP-DL
Manufacturer DATASCOPE CORP.
Product code DSP
Device class Class II
Date received by FDA Jul 29, 1996
Report date Jul 28, 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
  • 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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