BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN CONDOMS UNSPECIFIED

    MDR report key: 16425425 · Received February 23, 2023

    Report

    Report Number
    2280705-2023-00378
    Event Type
    Injury
    Date Received
    February 23, 2023
    Report Date
    February 15, 2023
    Manufacturer
    CHURCH & DWIGHT CO., INC
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2023-CDW-00378, 007711570A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A FEMALE CONSUMER (AGE UNSPECIFIED) WHO EXPERIENCED GONORRHEA, BURNING AND BUMPS ON HER VAGINA AFTER USING TROJAN CONDOMS UNSPECIFIED. THE CONSUMER'S MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER USED TROJAN CONDOMS UNSPECIFIED. LATER, SHE EXPERIENCED BURNING AND BUMPS IN VAGINA. SHE ALLEGED THAT IT GAVE HER GONORRHEA. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN CONDOMS UNSPECIFIED WAS NOT APPLICABLE. THE OUTCOME OF THE EVENTS WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630082 TROJAN CONDOMS UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other