MAUDE report

MAUDE report 31372: BEYOND SEVEN PLUS CONDOM

Malfunction · received Mar 20, 1996 · OKAMOTO USA, INC.

Key facts

MDR report key 31372
Report number MW4001109
Event type Malfunction
Brand name BEYOND SEVEN PLUS CONDOM
Manufacturer OKAMOTO USA, INC.
Product code HIS
Device class Class II
Date received by FDA Mar 20, 1996
Report date Nov 30, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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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