BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN LATEX CONDOM UNSPECIFIED

    MDR report key: 14047408 · Received April 7, 2022

    Report

    Report Number
    2280705-2022-00014
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 26, 2022
    Report Date
    April 7, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    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 ACTUALLY OCCURRED.

    Description of Event or Problem · 0

    A CONTACT WAS RECEIVED FROM A CONSUMER VIA FACEBOOK STATING THAT HE HAS TRIED NUMEROUS STYLES OF CONDOMS AND ALWAYS HAD AT LEAST ONE BREAK WHILE IN USE. ALLEGEDLY, HE HAD TO TAKE MEDICATION DUE TO CONTRACTING CHLAMYDIA AND THE FEMALE PARTNER HAD TO USE PLAN B PILLS. WE DO NOT HAVE MEDICAL RECORDS TO SUBSTANTIATE THIS EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171348 TROJAN LATEX CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O