BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENSTRUAL CUP

    MDR report key: 17019904 · Received May 30, 2023

    Report

    Report Number
    3014829931-2023-00006
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 25, 2023
    Manufacturer
    ROCKBROOK DAILY PRODUCTS CO., LIMITED
    Product Code
    HHE
    Adverse Event
    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. PLEASE NOTE THAT AN INVESTIGATION WAS PERFORMED ON A PREVIOUS ADVERSE EVENT COMPLAINT FOR LOT E1H01A IN WHICH NO MANUFACTURING OR QUALITY DEVIATIONS WERE FOUND.

    Description of Event or Problem · 0

    ON 03-MAY-2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 28-YEAR-OLD FEMALE WHO USED THE MENSTRUAL CUP. CONCOMITANT PRODUCTS INCLUDED UNSPECIFIED MENTAL HEALTH MEDICATIONS. ON (B)(6) 2023, THE CONSUMER INSERTED A SIZED TWO MENSTRUAL CUP FOR A HEAVY FLOW PERIOD. THE SAME DAY AFTER INSERTING THE MENSTRUAL CUP, IT BECAME STUCK IN HER VAGINAL CANAL. SHE COULD NOT REMOVE IT BY HERSELF. SHE NOTED THAT SHE USED THE PRODUCT PER THE INSTRUCTIONS. SHE ATTEMPTED TO TRY PULLING ON THE STEM AND USED HER FINGER TO TRY TO GET AROUND THE CUP. SHE EXPERIENCED SWELLING AND DECIDED TO TRY TO REMOVE THE CUP THE NEXT MORNING. SHE WAS UNSURE IF THE SWELLING WAS FROM THE CUP OR IF IT WAS DUE TO HER ATTEMPTS TO REMOVE IT. ON (B)(6) 2023 SHE WENT TO AN EMERGENCY ROOM (ER) FOR ASSISTANCE IN REMOVING THE CUP. SHE EXPERIENCED LOWER BACK PAIN. NO TESTING, LABORATORY TESTS, OR IMAGING WAS DONE. IT TOOK THREE DOCTORS WITH TOOLS TO EXTRACT THE CUP. HER BACK PAIN RESOLVED A FEW HOURS AFTER REMOVING THE PRODUCT. SHE WAS DISCHARGED FROM THE ER. THE PRODUCT WAS INSERTED FOR A TOTAL OF 24 HOURS. SHE TOOK TYLENOL (ACETAMINOPHEN) TO HELP WITH THE BACK PAIN. THE SWELLING RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448129 MENSTRUAL CUP MENSTRUAL CUP HHE ROCKBROOK DAILY PRODUCTS CO., LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention UNSPECIFIED MENTAL HEALTH MEDICATIONS