MAUDE report

MAUDE report 53416: RANGER CATHETER

Injury · received Nov 22, 1996 · SCIMED LIFE SYSTEMS, INC. DIV. OF BSC

Key facts

MDR report key 53416
Report number 2183819-1996-00058
Event type Injury
Brand name RANGER CATHETER
Model number R14 20/3.0
Catalog number 14361
Manufacturer SCIMED LIFE SYSTEMS, INC. DIV. OF BSC
Product code LOX
Device class Class II
Date received by FDA Nov 22, 1996
Report date Nov 21, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 10–99 Injury reports for this brand
  • Yes 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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