Description of Event or Problem · 1
CUSTOMER COMMENTED ON A (B)(6) POST NOTING HER IUD HAD BEEN DISLODGED WHILE WEARING HER CUP LAST YEAR. SHE CONTACTED US DIRECTLY AND NOTED THAT HER IUD WAS REMOVED/DISLODGED WHILE USING THE CUP AFTER WEARING IT FOR ABOUT 8 HOURS ONE DAY. SHE HAD USED THE CUP FOR SEVERAL CYCLES BEFORE THE IUD WAS DISLODGED. SHE BELIEVES HER IUD STRINGS WERE CUT SHORT, BUT THEY FELT LONGER AT THE TIME WHEN HER IUD CAME OUT. SHE NO LONGER USES A SAALT CUP. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED IN THE LABELING. THERE WERE NO DEVIATIONS, ERRORS, OMISSIONS, OR NON-CONFORMITIES THAT WERE NOTED TO BE ASSOCIATED WITH THE REPORTED DEVICE. THE EVENT IS NOT A NEW OR NOVEL EVENT, AND BASED ON THE SEVERITY OF THE INDIVIDUAL OCCURRENCE, NO CAPA IS REQUIRED AT THIS TIME. ADDITIONAL ACTIONS WHICH MAY INCLUDE CAPA ACTIVITY AND/OR ESCALATION OF NOTED ISSUES WILL BE TAKEN IF AN OUTLYING TREND FOR AN EVENT IS NOTED. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. INSTRUCTIONS FOR USE (IFU) STATES TO REMOVE THE CUP: "CONSIDER REMOVING YOUR CUP IN THE SHOWER OR WHILE SITTING ON A TOILET. ALWAYS PINCH THE GRIP RINGS AT THE BASE OF THE CUP TO BREAK THE SEAL (DON'T PULL ON THE STEM ALONE). WIGGLE YOUR CUP BACK AND FORTH WHILE HOLDING THE GRIP RINGS AND KEEP YOUR CUP UPRIGHT AS YOU PULL IT PAST YOUR LABIA TO AVOID SPILLING." IT ALSO STATES THAT "THE CUP CAN MOVE HIGHER IF A GOOD SEAL ISN'T FORMED WHEN FIRST INSERTED, BUT IT WILL NOT GET LOST IN THE VAGINA. WALK AROUND AND WAIT 30 MINUTES AND TRY AGAIN, OR USE YOUR PELVIC MUSCLES TO BEAR DOWN ON THE CUP, PUSHING IT LOWER. SQUATTING IN THE SHOWER CAN ALSO HELP. ONCE IN REACH, PINCH THE LOWER BASE OF CUP TO BREAK THE SEAL, AND THEN GENTLY PULL IT OUT." THE IFU FURTHER STATES THAT "UTERINE LINING CAN SOMETIMES GET STUCK INSIDE THE CUP AND BLOCK THE SUCTION HOLES MAKING IT DIFFICULT TO REMOVE THE CUP."