BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN LATEX CONDOM UNSPECIFIED

    MDR report key: 12174711 · Received July 15, 2021

    Report

    Report Number
    2280705-2021-00033
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    July 4, 2021
    Report Date
    July 15, 2021
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Adverse Event
    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 ALLEGES THAT SHE CONTRACTED A SEXUALLY TRANSMITTED DISEASE FROM THESE CONDOMS. WHILE THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION (BREAKAGE), IN THE ABSENCE OF CONFIRMATION, THIS COMPLAINT WILL BE CONSERVATIVELY REPORTED BASED ON THE ALLEGATION OF CONTRACTING AN STD. OF NOTE, THERE IS NOTHING IN A CONDOM TO CAUSE AN STD. ADDITIONALLY, SHE ALLEGES THAT HER BOYFRIEND GOT BUMPS ON HIS PENIS. LASTLY, SHE ALLEGES THAT HER CHILD TRIED EATING THE CONDOM AND ALMOST DIED. A LOT CODE SEARCH COULD NOT BE GENERATED FOR INCIDENT REVIEW AS THE CONSUMER DID NOT PROVIDE A LOT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074524 TROJAN LATEX CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1