BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN BARESKIN CONDOMS 3 CT

    MDR report key: 11028940 · Received December 17, 2020

    Report

    Report Number
    2280705-2020-00034
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 17, 2020
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE CONSUMER STATES THAT HE PURCHASED A BOX OF TROJAN BARESKIN CONDOMS AND THEY ALLEGEDLY BROKE EVERY TIME. HE FURTHER STATED THAT HE WEARS CONDOMS TO PROTECT HIMSELF AS HIS PARTNER HAS HEPATITIS C. IN THE ABSENCE OF CONFIRMATION, THIS IS REPORTABLE BASED ON THE ALLEGATION OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER STATES THAT HE PURCHASED A BOX OF TROJAN BARESKIN CONDOMS AND THEY ALLEGEDLY BROKE EVERY TIME. HE FURTHER STATED THAT HE WEARS CONDOMS TO PROTECT HIMSELF AS HIS PARTNER HAS (B)(6). IN THE ABSENCE OF CONFIRMATION, THIS IS REPORTABLE BASED ON THE ALLEGATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498859 TROJAN BARESKIN CONDOMS 3 CT CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1