BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 CT

    MDR report key: 10787927 · Received November 4, 2020

    Report

    Report Number
    2280705-2020-00028
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 29, 2020
    Report Date
    November 4, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    UDI-DI
    00022600947325
    PMA / PMN Number
    K120286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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 CO., INC. ACTUALLY OCCURRED.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT ONE OF THE CONDOMS BROKE AND THAT HE WAS WITH A PARTNER THAT MAY HAVE HAD GENITAL HERPES. WE ARE REPORTING THIS AS A MALFUNCTION WITH POTENTIAL EXPOSURE TO GENITAL HERPES AND IN THE ABSENCE OF ADDITIONAL INFORMATION FROM THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254298 TROJAN ECSTASY ULTRA RIBBED CONDOMS 10 CT CONDOM HIS CHURCH & DWIGHT CO., INC. 2260094732 TT0182D 00022600947325

    Patients

    Seq Age Sex Outcome Treatment
    1