MAUDE report

MAUDE report 4469: UNIFLATE 1000

Injury · received Jul 29, 1992 · SURGITEK MEDICAL ENGINEERING CORPORATION

Key facts

MDR report key 4469
Report number 4469
Event type Injury
Brand name UNIFLATE 1000
Model number UNIFLATE 1000
Catalog number 0259200
Manufacturer SURGITEK MEDICAL ENGINEERING CORPORATION
Product code FAE
Device class Class II
Date received by FDA Jul 29, 1992
Report date Jul 29, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes Adverse event flagged
  • No 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:

Browse all MAUDE medical device reports