MAUDE report

MAUDE report 24946: DALKON SHIELD IUD

Malfunction · received Aug 25, 1995 · A.H. ROBINS CO.

Key facts

MDR report key 24946
Report number MW4000693
Event type Malfunction
Brand name DALKON SHIELD IUD
Manufacturer A.H. ROBINS CO.
Product code HDT
Device class Class III
Date received by FDA Aug 25, 1995
Report date Apr 11, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 MAUDE reports for this product code
  • 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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