MAUDE report

MAUDE report 48981: CORODYN TD-E N THERMODILUTION BALLOON CATHETER

Malfunction · received Nov 7, 1996 · B BRAUN MEDICAL, INC. CARDIOVASCULAR DIV.

Key facts

MDR report key 48981
Report number 2243801-1996-00015
Event type Malfunction
Brand name CORODYN TD-E N THERMODILUTION BALLOON CATHETER
Model number 407-1HSK
Catalog number 417D1006/1HS80E
Manufacturer B BRAUN MEDICAL, INC. CARDIOVASCULAR DIV.
Product code DYG
Device class Class II
Date received by FDA Nov 7, 1996
Report date Sep 13, 1996
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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