MAUDE report

MAUDE report 4211: HI TORQUE FLOPPY II GUIDE WIRE

Injury · received Jul 9, 1992 · ADVANCED CARDIOVASCULAR SYSTEMS, INC.

Key facts

MDR report key 4211
Report number 4211
Event type Injury
Brand name HI TORQUE FLOPPY II GUIDE WIRE
Model number 22339M
Manufacturer ADVANCED CARDIOVASCULAR SYSTEMS, INC.
Product code DQX
Device class Class II
Date received by FDA Jul 9, 1992
Report date Jun 8, 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
  • 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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