MAUDE report

MAUDE report 2004: ASSORTED AORTIC CONNECTORS

Malfunction · received Nov 23, 1992 · CARDIOVASCULAR INSTRUMENT CORPORATION

Key facts

MDR report key 2004
Report number 1416557-1992-00004
Event type Malfunction
Brand name ASSORTED AORTIC CONNECTORS
Catalog number 66MC-2; 66MC-4; S-12-L
Manufacturer CARDIOVASCULAR INSTRUMENT CORPORATION
Product code CAI
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Nov 23, 1992
Report date Nov 20, 1992
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
  • None Death reports for this brand
  • None 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:

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