MAUDE report

MAUDE report 46615: BARALYME CARBON MONOXIDE

No Answer Provided · received Oct 30, 1996 · CHEMTRON MEDICAL DIVISION

Key facts

MDR report key 46615
Report number 1924066-1996-90005
Event type No Answer Provided
Brand name BARALYME CARBON MONOXIDE
Model number 44-01-0006
Catalog number 44-01-0006
Manufacturer CHEMTRON MEDICAL DIVISION
Product code CBL
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Oct 30, 1996
Report date Oct 15, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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
  • 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:

Browse all MAUDE medical device reports