BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN FIRE & ICE CONDOMS 3 CT

    MDR report key: 10788574 · Received November 4, 2020

    Report

    Report Number
    2280705-2020-00029
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 4, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    UDI-DI
    00022600960034
    PMA / PMN Number
    K120287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 STATED THAT HE PUT ON TWO CONDOMS AT ONE TIME AND HAD INTERCOURSE. THE OUTER CONDOM TORE AT THE TOP. HE FURTHER STATED THAT THE NEXT DAY IT BURNED WHEN HE URINATED. THE CONSUMER WENT TO THE EMERGENCY ROOM WHERE HE ALLEGES THAT HE TESTED POSITIVE FOR GENITAL HERPES. IN THE EMERGENCY ROOM, THEY RECOMMENDED AN OVER THE COUNTER CREAM AT (B)(4). HE STILL HAS ONGOING SYMPTOMS. WE DON'T HAVE MEDICAL RECORDS TO CONFIRM THIS DIAGNOSIS. ALSO, THERE WAS NO MENTION OF THE SECOND CONDOM BREAKING; HOWEVER, WE DON'T HAVE ADDITIONAL RECORDS TO CONFIRM THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247903 TROJAN FIRE & ICE CONDOMS 3 CT CONDOM HIS CHURCH & DWIGHT CO., INC. 2260096003 00022600960034

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR