MAUDE report

MAUDE report 70755: MEDELA

Injury · received Feb 17, 1997 · MEDELA AG

Key facts

MDR report key 70755
Report number 1419937-1997-09001
Event type Injury
Brand name MEDELA
Model number DOMINANT (TYPE 0250001)
Catalog number *
Manufacturer MEDELA AG
Product code HDB
Device class Class II
Date received by FDA Feb 17, 1997
Report date Feb 17, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 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:

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