BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEYOND SEVEN

    MDR report key: 3720577 · Received March 24, 2014

    Report

    Report Number
    9610410-2014-00001
    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
    PMA / PMN Number
    K893039
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    171912 BEYOND SEVEN CONDOM (RUBBER) CONTRACEPTIVE HIS OKAMOTO RUBBER PRODUCTS CO., LTD. 28373 71000 T182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other