MAUDE report

MAUDE report 39929: INFUSE-APORT INFUSION SET

Malfunction · received Sep 4, 1996 · STRATO/INFUSAID, INC

Key facts

MDR report key 39929
Report number 1219454-1996-00387
Event type Malfunction
Brand name INFUSE-APORT INFUSION SET
Catalog number 41129-1
Manufacturer STRATO/INFUSAID, INC
Product code FMI
Device class Class II
Date received by FDA Sep 4, 1996
Report date Sep 4, 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
  • 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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