BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN MAGNUM XL CONDOMS UNSPECIFIED

    MDR report key: 16851339 · Received May 2, 2023

    Report

    Report Number
    2280705-2023-00747
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 19, 2023
    Manufacturer
    CHURCH & DWIGHT CO., INC
    Product Code
    HIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2023-CDW-00747, 007756135A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A CONSUMER (AGE AND GENDER UNSPECIFIED) WHOSE CONDOM BROKE AND GOT EXPOSED TO HUMAN IMMUNODEFICIENCY VIRUS (HIV) WHILE USING TROJAN MAGNUM XL CONDOMS UNSPECIFIED. THE CONSUMER'S MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE NOT REPORTED. ON (B)(6) 2023, THE CONSUMER USED THE TROJAN MAGNUM XL CONDOMS UNSPECIFIED, USED ONE. THE CONSUMER STATED THAT THE CONDOM BROKE WHILE USING IT. THE CONSUMER GOT EXPOSED TO HIV, AS THE CONSUMER'S PARTNER HAD IT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN MAGNUM XL CONDOMS UNSPECIFIED AND THE EVENTS WERE NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124080 TROJAN MAGNUM XL CONDOMS UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other