BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN BRAND, MAGNUM SUB-BRAND

    MDR report key: 1822461 · Received August 26, 2010

    Report

    Report Number
    2280705-2010-00012
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 27, 2010
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    PMA / PMN Number
    K874383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR FURTHER EVAL, 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

    ON (B)(6)2010, A CONSUMER REPORTED BY PHONE THAT "3 OR 4 TIMES WE'VE HAD A CONDOM BREAK" AND AN "OBGYN FOUND A PIECE OF CONDOM LODGED IN MY CERVIX."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention