BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN LATEX CONDOM UNSPECIFIED

    MDR report key: 12340267 · Received August 18, 2021

    Report

    Report Number
    2280705-2021-00035
    Event Type
    Injury
    Date Received
    August 18, 2021
    Date of Event
    August 8, 2021
    Report Date
    February 4, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT AND THE INFORMATION SUBMITTED UNDER THIS REPORT DO NOT CONSTITUTE AN ADMISSION THAT THE DEVICE OR CHURCH & DWIGHT CO., INC. OR ANY OF ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED HEREIN OR THAT THE EVENT AS REPORTED TO CHURCH & DWIGHT CO., INC. ACTUALLY OCCURRED.

    Description of Event or Problem · 0

    A SOCIAL MEDIA CONTACT WAS RECEIVED FROM SOMEONE ALLEGING THAT ANOTHER PERSON GAVE HIS/HER FRIEND HIV WHEN A TROJAN CONDOM BROKE. IT WAS FURTHER STATED THAT THE TWO INDIVIDUALS INVOLVED WITH THE SEXUAL CONTACT DIDN'T KNOW CONDOMS COULD BREAK. WHILE THIS REPORTED EXPERIENCE CANNOT BE CONFIRMED (AS IT WAS REPORTED VIA SOCIAL MEDIA), IN THE ABSENCE OF CONFIRMATION, THIS COMPLAINT WILL BE REPORTABLE BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION, WITH THE ALLEGATION OF CONTRACTING AN STD. THIS CONTACT WILL BE REPORTED CONSERVATIVELY, AS THIS CAN BE A SERIOUS INJURY.

    Description of Event or Problem · 1

    A SOCIAL MEDIA CONTACT WAS RECEIVED FROM SOMEONE ALLEGING THAT ANOTHER PERSON GAVE HIS/HER FRIEND (B)(6) WHEN A TROJAN CONDOM BROKE. IT WAS FURTHER STATED THAT THE TWO INDIVIDUALS INVOLVED WITH THE SEXUAL CONTACT DIDN'T KNOW CONDOMS COULD BREAK. WHILE THIS REPORTED EXPERIENCE CANNOT BE CONFIRMED (AS IT WAS REPORTED VIA SOCIAL MEDIA), IN THE ABSENCE OF CONFIRMATION, THIS COMPLAINT WILL BE REPORTABLE BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION, WITH THE ALLEGATION OF CONTRACTING AN STD. THIS CONTACT WILL BE REPORTED CONSERVATIVELY, AS THIS CAN BE A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232350 TROJAN LATEX CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other