MAUDE report

MAUDE report 16086

Injury · received Jul 21, 1994 · MCGHAN MEDICAL

Key facts

MDR report key 16086
Report number 16086
Event type Injury
Model number SALINE 650CC
Catalog number 27-00168
Manufacturer MCGHAN MEDICAL
Product code FTR
Device class Class III
Date received by FDA Jul 21, 1994
Report date May 12, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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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