MAUDE report

MAUDE report 4277: POLY C CATH LAB

Malfunction · received Jul 1, 1992 · PHILIPS MEDICAL SYSTEM

Key facts

MDR report key 4277
Report number 4277
Event type Malfunction
Brand name POLY C CATH LAB
Model number PLY C/OM 200
Manufacturer PHILIPS MEDICAL SYSTEM
Product code DXG
Device class Class II
Date received by FDA Jul 1, 1992
Report date Feb 28, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 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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