BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN LATEX CONDOM UNSPECIFIED

    MDR report key: 11240414 · Received January 27, 2021

    Report

    Report Number
    2280705-2021-00004
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 16, 2021
    Report Date
    January 27, 2021
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    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. ADDITIONAL INFORMATION: THE CONSUMER DID NOT RESPOND TO FOLLOW-UP REQUESTS, SO WE WERE UNABLE TO OBTAIN THE MEDICAL DEVICE FOR FURTHER EXAMINATION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THAT THE CONDOMS RIPPED WHILE ENGAGING IN INTERCOURSE. THE CONSUMER ALSO ALLEGES CONTRACTING AIDS. IN THE ABSENCE OF CONFIRMATION, THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION, WITH THE ALLEGATION OF CONTRACTING AN STD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131103 TROJAN LATEX CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1