MAUDE report

MAUDE report 1654: MCGAW ADDITIV PRIMARY IV SET 15 DROPS/ML

Injury · received Nov 2, 1992 · MCGAW OF PUERTO RICO, INC.

Key facts

MDR report key 1654
Report number 1654
Event type Injury
Brand name MCGAW ADDITIV PRIMARY IV SET 15 DROPS/ML
Catalog number V1464
Manufacturer MCGAW OF PUERTO RICO, INC.
Product code FPK
Device class Class II
Date received by FDA Nov 2, 1992
Report date Oct 20, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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