BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN MAGNUM BARESKIN CONDOMS

    MDR report key: 11516007 · Received March 18, 2021

    Report

    Report Number
    2280705-2021-00007
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 18, 2021
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 STATED THAT HER BOYFRIEND HAS HERPES. THEY PURCHASED THESE CONDOMS TO PROTECT HER DURING INTERCOURSE. SHE ALLEGES THAT TWO OUT OF FIVE CONDOMS BROKE DURING INTERCOURSE. SHE IS NOW CONCERNED ABOUT THE POSSIBILITY OF HAVING CONTRACTED HERPES. THIS IS BEING REPORTED BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION WITH THE ALLEGATION OF POSSIBLY CONTRACTING AN STD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419167 TROJAN MAGNUM BARESKIN CONDOMS CONDOM HIS CHURCH & DWIGHT CO., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1