MAUDE report

MAUDE report 81647: TERUMO AVF SET

Injury · received Apr 4, 1997 · TERUMO MEDICAL CORP (MD) EAST

Key facts

MDR report key 81647
Report number 1118880-1997-00077
Event type Injury
Brand name TERUMO AVF SET
Catalog number AVE 15C
Manufacturer TERUMO MEDICAL CORP (MD) EAST
Product code FIE
Device class Class II
Date received by FDA Apr 4, 1997
Report date Mar 5, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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