BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENSTRUAL CUP

    MDR report key: 16639543 · Received March 29, 2023

    Report

    Report Number
    3014829931-2023-00003
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 20, 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

    A NON-CONFORMANCE WAS ISSUED TO THE CONTRACT MANUFACTURER FOR THE EVENT. THE CONTRACT MANUFACTURER COMPLETED AN INVESTIGATION AND SENT THE FINDINGS TO THE HONEY POT QA TEAM ON 3/13/2023. NO QUALITY ISSUES WERE REPORTED DURING THE MANUFACTURING OR PACKAGING OF THE MENSTRUAL CUPS, LOT E1H01A. THE CONTRACT MANUFACTURER CONCLUDED THAT THE ADVERSE EVENT WAS CAUSED BY USAGE ERROR.

    Description of Event or Problem · 0

    03-MAR-2023, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL REGARDING A 22-YEAR-OLD FEMALE WHO USED A MENSTRUAL CUP. ON 07-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. ON (B)(6) 2023, THE CONSUMER WORE THE MENSTRUAL CUP OVERNIGHT. APPROXIMATELY 10 HOURS LATER ON (B)(6) 2023, SHE EXPERIENCED VAGINAL BLEEDING AND CRAMPING. SHE COULD NOT FIND THE STEM TO REMOVE THE PRODUCT. SUBSEQUENTLY, SHE WENT TO AN EMERGENCY ROOM (ER). THE ER DOCTOR USED INSTRUMENTS TO REMOVE THE PRODUCT THUS CAUSING A TEAR IN THE CERVIX. THE REMOVAL CAUSED PAIN, DISCOMFORT, AND BLOOD LOSS. THE ER DOCTOR ADVISED HER TO CONSULT AN OBGYN IF BLEEDING HAD NOT STOPPED WITHIN 2-3 DAYS. ON (B)(6) 2023, SHE EXPERIENCED A LEAKING BLADDER. ON (B)(6) 2023, THE CRAMPING AND BLEEDING STOPPED. ON (B)(6) 2023, SHE STILL HAD DISCOMFORT AND BLADDER LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172256 MENSTRUAL CUP CUP, MENSTRUAL HHE ROCKBROOK DAILY PRODUCTS CO., LIMITED E1H01A

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention AMITRIPTYLINE.| TOPIRAMATE.