Description of Event or Problem · 0
ON JANUARY 4, 2024 SUNNY BECAME AWARE OF A COMMENT THAT WAS MADE ON A SOCIAL MEDIA POST IN OCTOBER 2023. THE CUSTOMER CLAIMED THAT WHILE USING THE SUNNY CUP + APPLICATOR, THEIR CUP BECAME STUCK AND THEY HAD TO SEEK MEDICAL CARE AT URGENT CARE AND THEN THE ER IN ORDER TO HAVE IT REMOVED. ONCE SUNNY BECAME AWARE OF THIS COMMENT, THEY REACHED OUT TO THE CUSTOMER FOR MORE INFORMATION VIA EMAIL ON JANUARY, 4, 2024, JANUARY 8, 2024, AND JANUARY 17, 2024. AS OF JANUARY 31, 2024 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.