BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN BRAND CONDUM (SUB BRAND UNK)

    MDR report key: 1052622 · Received May 27, 2008

    Report

    Report Number
    2280705-2008-00001
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 28, 2008
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR FURTHER EVALUATION, CHURCH & DWIGHT CO., INC. HAS REQUESTED THE FOLLOWING FROM THE USER: THE PRODUCT, ITS ORIGINAL PACKAGING, AND COMPLETION OF AN EVENT QUESTIONNAIRE. TO DATE, THE REQUESTED HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED IN AN E-MAIL IN 2008: "ONE MONTH BEFORE, I USED A TROJAN BRAND CONDOM...NOT UNTIL I HAD FINISHED WITH THE PRODUCT THAT I NOTICED ... A CHUNK OF JAGGED AND VERY RIGID LATEX FUSED TO THE INSIDE WALL OF THE PRODUCT... CAUSED SUBSTANTIAL FRICTION DAMAGE AND BRUISING TO THE SKIN AND TISSUE UNDERNEATH AND ENDED UP RUPTURING LESS THAN 10 MINS AFTER A I REMOVED THE PRODUCT. I HAD TO GO TO AN URGENT CARE CLINIC THE NEXT MORNING BECAUSE IT WAS VERY PAINFUL AND VERY SENSITIVE TO MOVEMENT OR TOUCH. I WAS TOLD THAT THE AREA WOULD LEAVE A NOTICEABLE [SIC] SCAR. IT HAS BEEN ONE MONTH AND THERE IS A VERY NOTICABLE [SCI] SCAR ABOUT 2.5 INCHES LONG RAISED AND OFF COLOR IN APPEARANCE. IN ADDITION THE AREA HAS CONTINUED TO BE HYPER SENSITIVE TO THE TOUCH TO THE POINT OF BEING PAINFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROJAN BRAND CONDUM (SUB BRAND UNK) MALE LATEX CONDUM, SECTION 884.5300 HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability