BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FC1 FEMALE CONDOM

    MDR report key: 2627380 · Received June 25, 2009

    Report

    Report Number
    1422723-2009-00001
    Event Type
    Injury
    Date Received
    June 25, 2009
    Date of Event
    June 22, 2009
    Report Date
    June 24, 2009
    Manufacturer
    THE FEMALE HEALTH CO.
    Product Code
    MBU
    PMA / PMN Number
    P910064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE CONTACT (B)(6), IF ADDITIONAL INFORMATION REQUIRED.

    Description of Event or Problem · 1

    USER MISUSED THE FC1 FEMALE CONDOM. USER USED FC1 FOR ANAL SEX AND WAS UNABLE TO REMOVE THE DEVICE (SHEATH AND INNER RING). USER WENT TO EMERGENCY ROOM TO HAVE DEVICE REMOVED. USER RELEASED FROM EMERGENCY ROOM (NOT HOSPITALIZED). THE DEVICE WAS NOT TORN. HIS TISSUES WERE NOT DAMAGED. MINOR IRRITATION FROM THE REMOVAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC1 FEMALE CONDOM FCI MBU THE FEMALE HEALTH CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention