BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROJAN LATEX CONDOM UNSPECIFIED

    MDR report key: 12516323 · Received September 22, 2021

    Report

    Report Number
    2280705-2021-00041
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 22, 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

    A CONTACT WAS RECEIVED VIA INSTAGRAM FROM SOMEONE WHO ALLEGES THAT HE INHALED A CONDOM DURING ORAL SEX AND CHOKED. HE ALSO ALLEGES THAT HE SOUGHT MEDICAL ATTENTION IN THE ER AND HAD SURGERY. THE CONSUMER DID NOT RESPOND TO A FOLLOW-UP REQUEST TO OBTAIN MORE INFORMATION ABOUT HIS EXPERIENCE. THIS PRODUCT WAS NOT USED AS PER LABEL, AS IT IS NOT MEANT TO BE INHALED. THE REPORTED EXPERIENCE CANNOT BE CONFIRMED, NOR CAN THE PRODUCT BE ELIMINATED AS A POTENTIAL CONTRIBUTORY FACTOR FOR THE REPORTED SYMPTOMS. IN THE ABSENCE OF CONFIRMATION, THIS CONTACT WILL BE REPORTED CONSERVATIVELY, AS THIS CAN BE A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408677 TROJAN LATEX CONDOM UNSPECIFIED CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR