BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPERMICIDALLY LUBRICATED CONDOM

    MDR report key: 197746 · Received November 17, 1998

    Report

    Report Number
    1019632-1998-00005
    Event Type
    Other
    Date Received
    November 17, 1998
    Date of Event
    September 2, 1998
    Report Date
    September 3, 1998
    Manufacturer
    ANSELL, INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ANSELL TO REPORT THAT HE SOUGHT MEDICAL ATTENTION DUE TO IRRITATION EXPERIENCED AFTER USING A LIFESTYLES CONDOM CONTAINING SPERMICIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPERMICIDALLY LUBRICATED CONDOM CONTRACEPTIVE DEVICE HIS ANSELL, INC. NA 801153700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other