BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEYOND SEVEN

    MDR report key: 4777195 · Received April 8, 2015

    Report

    Report Number
    2431332-2015-00001
    Event Type
    Injury
    Date Received
    April 8, 2015
    Date of Event
    January 1, 2015
    Report Date
    April 8, 2015
    Manufacturer
    OKAMOTO RUBBER PRODUCTS CO LTD.,
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE CONDOM WAS BROKEN AND RESULTED IN HIS GIRLFRIEND PREGNANT.MFR#: 9610410-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234022 BEYOND SEVEN CONDOM (RUBBER) CONTRACEPTIVE HIS OKAMOTO RUBBER PRODUCTS CO LTD., 28373 71000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other