MAUDE report

MAUDE report 2163: AUTOLET LITE CLINISAFE

Malfunction · received Jan 14, 1993 · ULSTER SCIENTIFIC, INC.

Key facts

MDR report key 2163
Report number 33644-1992-00064
Event type Malfunction
Brand name AUTOLET LITE CLINISAFE
Model number H0212
Catalog number HO212
Manufacturer ULSTER SCIENTIFIC, INC.
Date received by FDA Jan 14, 1993
Report date Dec 26, 1992
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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