BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROJAN-ENZ CONDOMS

    MDR report key: 16004400 · Received December 19, 2022

    Report

    Report Number
    2280705-2022-01823
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Report Date
    December 1, 2022
    Manufacturer
    CHURCH & DWIGHT CO., INC
    Product Code
    HIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT (2022-CDW-01823, 007665981A) FROM THE UNITED STATES OF AMERICA WAS REPORTED BY A FEMALE CONSUMER (AGE UNSPECIFIED) WHO HAD CONDOM STUCK INSIDE HER COINCIDENT WITH THE USE OF TROJAN-ENZ CONDOMS. THE CONSUMER'S MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B)(6) 2022 (3 WEEKS PRIOR TO THIS REPORT), THE CONSUMER USED TROJAN-ENZ CONDOMS. WHILE USING THE CONDOM, IT GOT STUCK INSIDE HER FOR QUITE SOME TIME. AFTER 3 WEEKS, IT CAME OUT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE ACTION TAKEN WITH TROJAN-ENZ CONDOMS AND THE OUTCOME OF THE EVENT WAS NOT APPLICABLE. COMPANY COMMENT: THERE WAS NO MENTION OF MEDICAL TREATMENT RECEIVED IN THE COMMUNICATION WITH THE CONSUMER. ALTHOUGH NOT EXPLICITLY STATED BY THE CONSUMER, CHURCH & DWIGHT CONSIDERS THIS TO BE A CASE OF CONDOM SLIPPAGE AND IS REPORTING CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201274 TROJAN-ENZ CONDOMS CONDOM HIS CHURCH & DWIGHT CO., INC KT1085265

    Patients

    Seq Age Sex Outcome Treatment
    1 Female