BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN-ENZ CONDOMS UNSPECIFIED

    MDR report key: 20519864 · Received October 24, 2024

    Report

    Report Number
    2280705-2024-01683
    Event Type
    Injury
    Date Received
    October 24, 2024
    Report Date
    October 24, 2024
    Manufacturer
    CHURCH & DWIGHT CO.,
    Product Code
    HIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOT AVAIL.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT ((B)(4), (B)(6)) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A MALE CONSUMER (AGE UNSPECIFIED) WHOSE CONDOM BROKE AND HE DEVELOPED A TERRIBLE SEXUALLY TRANSMITTED INFECTION (STI) AND ALLEGED THAT IT DID NOT WORK AFTER USING THE TROJAN-ENZ CONDOMS UNSPECIFIED. ON AN UNSPECIFIED DATE, THE CONSUMER INITIATED TROJAN-ENZ CONDOMS UNSPECIFIED. DURING INTERCOURSE, ONE OF HIS CONDOMS BROKE, AND HE ALLEGED THAT IT DID NOT WORK. LATER, HE DEVELOPED A TERRIBLE SEXUALLY TRANSMITTED INFECTION (STI) AND CONFIRMED THAT HE BECAME FATHER. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN-ENZ CONDOMS UNSPECIFIED WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS BROKE AND DID NOT WORK WAS NOT APPLICABLE. THE OUTCOME OF THE EVENT SEXUALLY TRANSMITTED INFECTION WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568678 TROJAN-ENZ CONDOMS UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., NOT AVAIL. NOT AVAIL.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other