BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEYOND SEVEN

    MDR report key: 3716656 · Received March 24, 2014

    Report

    Report Number
    2431332-2014-00001
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 24, 2014
    Manufacturer
    OKAMOTO RUBBER PRODUCTS CO LTD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER COMPLAINED THAT THE CONDOM WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173456 BEYOND SEVEN CONDOM (RUBBER) CONTRACEPTIVE HIS OKAMOTO RUBBER PRODUCTS CO LTD. 28373 71000 T182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other