MAUDE report

MAUDE report 83151: TRU-TRAC DILATATION CATH

Other · received Apr 7, 1997 · CR BARD, RADIOLOGY DIV.

Key facts

MDR report key 83151
Report number 1058665-1997-00023
Event type Other
Brand name TRU-TRAC DILATATION CATH
Catalog number 0058564
Manufacturer CR BARD, RADIOLOGY DIV.
Product code LIT
Device class Class II
Date received by FDA Apr 7, 1997
Report date Mar 3, 1997
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
  • 1–9 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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