MAUDE report

MAUDE report 3553: OMNI FILTER

Injury · received Dec 11, 1992 · PURITAN BENNETT

Key facts

MDR report key 3553
Report number 3553
Event type Injury
Brand name OMNI FILTER
Catalog number 4-006-308-00
Manufacturer PURITAN BENNETT
Product code CAH
Device class Class II
Date received by FDA Dec 11, 1992
Report date Dec 11, 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:

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