BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN BARESKIN CONDOMS 24 CT

    MDR report key: 13791101 · Received March 17, 2022

    Report

    Report Number
    2280705-2022-00010
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 16, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC.
    Product Code
    HIS
    UDI-DI
    00022600998532
    PMA / PMN Number
    K090259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    AN AMAZON REVIEW WAS RECEIVED FROM A CONSUMER STATING THAT MULTIPLE PACKS OF TROJAN BARESKIN CONDOMS HAVE BROKEN. THE CONSUMER ALLEGES THAT PLAN B WAS PURCHASED IN ADDITION TO GOING FOR STI TESTING. IN THE ABSENCE OF CONFIRMATION, THIS COMPLAINT WILL BE CONSERVATIVELY REPORTED BASED ON THE ALLEGATION OF A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387827 TROJAN BARESKIN CONDOMS 24 CT CONDOM HIS CHURCH & DWIGHT CO., INC. 2260099853 00022600998532

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown