MAUDE report

MAUDE report 4102: #3.0 SPECTRUM

Malfunction · received Jul 30, 1992 · ADVANCED CARDIOVASCULAR SYSTEMS

Key facts

MDR report key 4102
Report number 4102
Event type Malfunction
Brand name #3.0 SPECTRUM
Model number 3.0 X 20 MM SPECTRUM
Catalog number UNKNOWN
Manufacturer ADVANCED CARDIOVASCULAR SYSTEMS
Product code MJR
Date received by FDA Jul 30, 1992
Report date Mar 19, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1–9 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:

Browse all MAUDE medical device reports