MAUDE report

MAUDE report 7165

Malfunction · received Nov 9, 1993 · MEDICAL ENGINEERING CORP.

Key facts

MDR report key 7165
Report number 7165
Event type Malfunction
Model number LM02056-00 ROUND Q-S STERILE
Catalog number 11630000S0
Manufacturer MEDICAL ENGINEERING CORP.
Product code FTR
Device class Class III
Date received by FDA Nov 9, 1993
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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