BEUDAMED
    FDA Adverse Event Other Summary report: N

    TROJAN RIBBED CONDOM WITH NONOXYNOL 9

    MDR report key: 32516 · Received May 2, 1996

    Report

    Report Number
    MW1009002
    Event Type
    Other
    Date Received
    May 2, 1996
    Date of Event
    March 20, 1996
    Report Date
    March 22, 1996
    Manufacturer
    CARTER-WALLACE, INC.
    Product Code
    LTZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT BELIEVES HE IS REACTING TO THE SPERMICIDE. PT USED 1 CONDOM 3/20 PM AND 3/21 AM. PT REPORTS VERY SEVERE BURNING AT THE URETHRAL OPENING ON URINATION, REDNESS AND INDURATION OF APPROX 2-3 ML AROUND TIP. NO BLOOD OR DISCHARGE SEEN. PT INDICATED A SIMILAR BUT MUCH LESS SEVERE RESPONSE OCCURRED WITH THE SAME PRODUCT ABOUT 1 YEAR AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROJAN RIBBED CONDOM WITH NONOXYNOL 9 CONDOM WITH NONOXYNOL 9 LTZ CARTER-WALLACE, INC. 29941

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other