BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALITY

    MDR report key: 100723 · Received June 25, 1997

    Report

    Report Number
    MW4001928
    Event Type
    Malfunction
    Date Received
    June 25, 1997
    Report Date
    April 24, 1997
    Manufacturer
    FEMALE HEALTH CO.
    Product Code
    MBU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED IN THE REPORT, IT IS NOT POSSIBLE TO CONDUCT AN INVESTIGATION AND RESPOND TO QUESTIONS 1-3. THE FEMALE CONDOM HAS AN OUTER RING THAT IS INTENDED TO COVER THE LABIA AND TO PREVENT THE ENTIRE CONDOM FROM ENTERING THE VAGINA DURING INTERCOURSE. ON OCCASION, CONSUMERS MAY NEED TO ADD ADD'L LUBRICANT TO THE CONDOM TO PREVENT THE PENIS FROM PUSHING THE OUTER RING INTO THE VAGINA. THE DIRECTIONS FOR USE ADDRESS THIS POSSIBILITY AND ALERT THE CONSUMER TO USE MORE LUBRICANT IF THE OUTER RING IF PUSHED INTO THE VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALITY FEMALE CONDOM MBU FEMALE HEALTH CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *