MAUDE report

MAUDE report 17314: LITHOTRIPER EHL UNIT

Malfunction · received Jul 21, 1994 · NORTHGATE TECH.

Key facts

MDR report key 17314
Report number 17314
Event type Malfunction
Brand name LITHOTRIPER EHL UNIT
Model number SD-100
Manufacturer NORTHGATE TECH.
Date received by FDA Jul 21, 1994
Report date Feb 14, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 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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