BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENSTRUAL MATES, INC DBA SUNNY

    MDR report key: 24180125 · Received January 26, 2026

    Report

    Report Number
    3027115741-2026-00002
    Event Type
    Injury
    Date Received
    January 26, 2026
    Date of Event
    May 26, 2024
    Report Date
    January 26, 2026
    Manufacturer
    MENSTRUAL MATES, INC DBA SUNNY
    Product Code
    HHE
    UDI-DI
    00860009638617
    PMA / PMN Number
    K233361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS MANUFACTURED TO ALL REQUIRED SPECIFICATIONS. AFTER A REVIEW OF THE MAUDE DATABASE, THIS APPEARS TO BE AN ISSUE THAT IS SEEN OFTEN WITH MENSTRUAL CUPS. ONGOING RESEARCH WILL BE DONE TO DETERMINE IF THERE ARE WAYS TO PREVENT THIS EVENT FROM HAPPENING IN THE FUTURE.

    Description of Event or Problem · 0

    ON JANUARY 6, 2026 SUNNY WAS MADE AWARE OF A CUSTOMER COMPLAINT VIA EMAIL. THE CUSTOMER CLAIMED THAT WHILE USING THE SUNNY CUP + APPLICATOR, THEIR CUP BECAME STUCK AND THEY HAD TO SEEK MEDICAL CARE AT URGENT CARE TO HAVE IT REMOVED. THIS CUSTOMER ALSO NOTED THAT THEY HAVE PHYSICAL CONSTRAINTS, INCLUDING HYPERMOBILITY ISSUES AND A HIGH CERVIX, THAT MAKE REACHING THE INSERTED CUP DIFFICULT. ONCE SUNNY BECAME AWARE OF THIS EVENT, THEY REACHED OUT TO THE CUSTOMER 2 TIMES (JANUARY 7, 2026, AND JANUARY 14, 2026) FOR MORE INFORMATION. THE CUSTOMER HAS NOT YET RESPONDED. NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE. SUNNY BELIEVES THE INSTRUCTIONS GIVEN IN THE INSTRUCTIONS FOR USE ARE AN ADEQUATE DIRECTIVE FOR THE REMOVAL OF THE MENSTRUAL CUP. THE IFU STATES: "LOCATE THE BASE OF YOUR CUP" "IF YOU CANNOT REACH IT, GENTLY PUSH LIKE YOU'RE HAVING A BOWEL MOVEMENT" "USE THE STEM AS A GUIDE UNTIL YOU CAN REACH THE BASE OF YOUR CUP. PINCH THE BASE OF YOUR CUP TO BREAK THE SEAL. WITH THE BASE PINCHED, GENTLY PULL DOWN TO REMOVE YOUR CUP." THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246599 MENSTRUAL MATES, INC DBA SUNNY SUNNY CUP + APPLICATOR HHE MENSTRUAL MATES, INC DBA SUNNY SUNAC011PEGI01 102623 00860009638617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention