MAUDE report

MAUDE report 13394: LIFECARE OMNI-FLOW INFUSION SET

Injury · received May 19, 1994 · ABBOTT LABORATORIES

Key facts

MDR report key 13394
Report number MW1002107
Event type Injury
Brand name LIFECARE OMNI-FLOW INFUSION SET
Model number 11169
Manufacturer ABBOTT LABORATORIES
Product code FPA
Device class Class II
Date received by FDA May 19, 1994
Report date May 6, 1994
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
  • 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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