BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN LATEX CONDOMS UNSPECIFIED

    MDR report key: 9598105 · Received January 16, 2020

    Report

    Report Number
    2280705-2020-00003
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 30, 2019
    Report Date
    January 17, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THIS REPORT HAS BEEN CORRECTED TO REMOVE THE STATEMENT THAT WAS IN THE INITIAL REPORT IN SECTION H10 REGARDING THE REPORT BEING SUBMITTED LATE DUE TO TECHNICAL ISSUES.

    Description of Event or Problem · 0

    THE CONSUMER STATED THAT HE USED THESE CONDOMS ALL OF HIS LIFE AND THEY BREAK EVERYTIME. THE CONSUMER ALSO STATED THAT HE HAD TO GET A STD TEST AFTER THIS HAPPENED. HE ALSO ALLEGES THAT A FRIEND OF HIS IS CURRENTLY UNDERGOING A PEP TREATMENT BECAUSE THE CONDOM BROKE.

    Additional Manufacturer Narrative · 1

    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. ALSO, PLEASE NOTE THAT THIS REPORT IS BEING SUBMITTED LATE DUE TO TECHNICAL ISSUES WITH THE ESG HELP DESK ESTABLISHING MY PRODUCTION ACCOUNT. ALL EMAILS WITH THE ESG HELP DESK REGARDING THIS ISSUE HAVE BEEN SAVED AND CAN BE PROVIDED IF NECESSARY.

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT HE USED THESE CONDOMS ALL OF HIS LIFE AND THEY BREAK EVERY TIME. THE CONSUMER ALSO STATED THAT HE HAD TO GET A STD TEST AFTER THIS HAPPENED. HE ALSO ALLEGES THAT A FRIEND OF HIS IS CURRENTLY UNDERGOING A PEP TREATMENT BECAUSE THE CONDOM BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57741 TROJAN LATEX CONDOMS UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention