BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC FEMALE CONDOM

    MDR report key: 336336 · Received June 5, 2001

    Report

    Report Number
    1422723-2001-00001
    Event Type
    Other
    Date Received
    June 5, 2001
    Date of Event
    May 9, 2001
    Report Date
    June 4, 2001
    Manufacturer
    THE FEMALE HEALTH CO.
    Product Code
    MBU
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER USED FEMALE CONDOM AND NOTED OUTER RING PULLED INSIDE VAGINA DURING USE. TWO MONTHS LATER, AFTER SUFFERING A LIGHT PERIOD IN THE INTERIM, PT WENT TO SEE THEIR PHYSICIAN BECAUSE IF "HEMMORAGE". PHYSICIAN ADVISED THAT PT HAD MISCARRIED. CUSTOMER HAS TWO CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26165 FC FEMALE CONDOM FEMALE CONDOM BARRIER DEVICE MBU THE FEMALE HEALTH CO. * 2447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other