MAUDE report

MAUDE report 3653: HI-LO TRACHEAL TUBE

Injury · received Jul 9, 1992 · MALLINCRODT CRITICAL CARE

Key facts

MDR report key 3653
Report number 3653
Event type Injury
Brand name HI-LO TRACHEAL TUBE
Model number 86113
Manufacturer MALLINCRODT CRITICAL CARE
Product code BTR
Device class Class II
Date received by FDA Jul 9, 1992
Report date Feb 18, 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:

Browse all MAUDE medical device reports