MAUDE report

MAUDE report 16620: ALCON SERIES 10,000 UNIPAK

Other · received Mar 2, 1994 · ALCON SURGICAL

Key facts

MDR report key 16620
Report number 16620
Event type Other
Brand name ALCON SERIES 10,000 UNIPAK
Model number 316 1638 001 REV D
Catalog number 10530F
Manufacturer ALCON SURGICAL
Date received by FDA Mar 2, 1994
Report date Jan 4, 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
  • Yes 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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