BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENSTRUAL CUP SIZE 2

    MDR report key: 22213216 · Received June 16, 2025

    Report

    Report Number
    3014829931-2025-00004
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    September 1, 2024
    Report Date
    June 16, 2025
    Manufacturer
    ROCKBROOK DAILY PRODUCTS CO.,LIMITED
    Product Code
    HHE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS NO LOT NUMBER WAS PROVIDED BY THE CONSUMER AN INVESTIGATION WITH THE MANUFACTURER WAS NOT POSSIBLE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SPONTANEOUS REPORT WAS RECEIVED VIA EMAIL REGARDING A 43-YEAR-OLD FEMALE WHO USED THE HONEY POT MENSTRUAL CUP. ON APPROXIMATELY (B)(6) 2024, THE CONSUMER STARTED USING THE HONEY POT MENSTRUAL CUP (SIZE 2) DURING HER MENSTRUATION CYCLE FOR APPROXIMATELY 6 MONTHS. ON AN UNSPECIFIED DATE IN (B)(6) 2024, THE CONSUMER NOTED THE TAB ON THE CUP BROKE OFF WHILE SHE WAS TRYING TO PULL IT OUT. THE CUP BECAME STUCK INSIDE HER AND SHE IMMEDIATELY WENT TO THE EMERGENCY ROOM (ER) FOR PRODUCT REMOVAL ASSISTANCE. THE ER DID NOT GIVE ANY DIAGNOSTIC TESTS. SHE WAS DISCHARGED THE SAME DAY WITHOUT PRESCRIPTIONS OR REFERRALS. SHE DISCONTINUED USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956914 MENSTRUAL CUP SIZE 2 MENSTRUAL CUP HHE ROCKBROOK DAILY PRODUCTS CO.,LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention