BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN BRAND LUBRICATED CONDOM, HER PLEASURE

    MDR report key: 1140082 · Received August 28, 2008

    Report

    Report Number
    2280705-2008-00004
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    PMA / PMN Number
    912901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR FURTHER EVALUATION, CHURCH & DWIGHT CO., INC. HAS REQUESTED THE FOLLOWING FROM THE USER: THE PRODUCT, ITS ORIGINAL PACKAGING, AND COMPLETION OF AN EVENT QUESTIONNAIRE. TO DATE, THE REQUESTED HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    VIA EMAIL, THE CONSUMER REPORTED IN 2008, THAT SHE HAS TAKEN "A TRIP TO THE ER FOR THE SECOND TIME USING ONE OF YOUR PRODUCTS... A WHILE AGO,...I USED YOUR CONDOMS WITH SPERMICIDAL LUBRICANT, WHICH ENDED UP WITH ME BEING IN THE HOSPITAL THREE WEEKS LATER BECAUSE I COULDN'T URINATE... I HAD AN E. COLI INFECTION... AFTER USING THE UNLUBRICATED BRAND FOR SOMETIME WE SAW YOUR PLEASURE PACK... MY HUSBAND USED THE 'HER PLEASURE' CONDOM THAT WAS IN THE PACK- AND SURE ENOUGH, A WEEK AND A HALF LATER IM [SIC] HEADED TO THE ER AGAIN... I HAD A HORRIBLE KIDNEY INFECTION DUE TO THE LUBRICANT USED ON YOUR CONDOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROJAN BRAND LUBRICATED CONDOM, HER PLEASURE MALE LATEX CONDOM, SECTION 884.5300 HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R