MAUDE report

MAUDE report 4032: CO2 SURGICAL LASER

Malfunction · received May 6, 1992 · COHERENT

Key facts

MDR report key 4032
Report number 4032
Event type Malfunction
Brand name CO2 SURGICAL LASER
Model number ULTRAPULSE 4000
Manufacturer COHERENT
Product code EWG
Device class Class II
Date received by FDA May 6, 1992
Report date Mar 11, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None 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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