BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED

    MDR report key: 15273245 · Received August 23, 2022

    Report

    Report Number
    2280705-2022-01209
    Event Type
    Injury
    Date Received
    August 23, 2022
    Report Date
    August 6, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2022-CDW-01209, 007595010A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A MALE CONSUMER (AGE UNSPECIFIED) WHOSE CONDOM WAS BROKEN AND DEVELOPED A SEXUALLY TRANSMITTED DISEASE (STD) COINCIDENT WITH TROJAN LATEX BARESKIN LUBRICATED CONDOMS (TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED). THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER USED TROJAN LATEX BARESKIN LUBRICATED CONDOMS (TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED). HE STATED THAT THE CONDOM WAS BROKEN AND HE DEVELOPED STD. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN LATEX BARESKIN LUBRICATED CONDOMS (TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED) WAS UNKNOWN. THE OUTCOME OF THE SEXUALLY TRANSMITTED DISEASE WAS UNKNOWN. THE OUTCOME OF THE CONDOM BREAK WAS NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393489 TROJAN BARESKIN RAW LUBRICATED CONDOMS UNSPECIFIED TROJON CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other