BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN BRAND, FIRE & ICE SUB-BRAND

    MDR report key: 2003840 · Received February 24, 2011

    Report

    Report Number
    2280705-2011-00006
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    PMA / PMN Number
    K912901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    ON (B)(6) 2011 A CONSUMER REPORTED BY PHONE THAT HIS WIFE "GOT A YEAST INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROJAN BRAND, FIRE & ICE SUB-BRAND MALE LATEX CONDOM, SECTION 884.5300 HIS CHURCH & DWIGHT CO., INC. TT0252X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention