Cora 10MENSTRUALCUP-S1DTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850003218380), received between May 5, 2021 and Feb 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2024Expulsion; Compatibility Problem; Expulsion; Compatibility Problem

  USER REPORTED THEIR IUD DISLODGED ON THE FIRST DAY OF USE WITH A NEW CORA CUP. USER REPORTS THAT THEY THINK THEY HEARD THE SEAL BREAK BEFORE TRYING TO REMOVE IT. USER STATED THAT THEY CHECK THE IUD STRING BEFORE AND AFTER EACH USE, BUT THE LAST TIME THE USER REMOVED IT THE USER FELT THE IUD STICKING OUT OF THE CERVIX. USER SOUGHT MEDICAL ATTENTION TO REMOVE DISLOCATED IUD, HOWEVER IUD BROKE DURING REMOVAL. USER NOW REQUIRES HYSTEROSCOPY UNDER GENERAL ANESTHESIA TO REMOVE BROKEN IUD. NO INJURIES OR MEDICATIONS REPORTED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Intermenstrual Bleeding; Menstrual Irregularities

  MAUDE report 18640168 ↗
• InjuryJun 6, 2022Expulsion; Compatibility Problem; Expulsion; Compatibility Problem

  USER CONTACTED SUPPORT CLAIMING THAT AN ALLERGIC REACTION TO THE MENSTRUAL DISC (SILICONE) CAUSED LOCALIZED CYST DEVELOPMENT. LOCATION, SIZE, AND NUMBER OF CYSTS WAS NOT COMMUNICATED. USER STATED A PERSONAL MEDICAL HISTORY INVOLVING ALLERGIES TO A SPERMICIDAL SPONGE (POLYURETHANE) WHICH ALSO CAUSED CYST DEVELOPMENT, AND AN ALLERGY TO NEOPRENE WHICH CAUSES WELTS AND ECZEMA. THIS IS BEING CONSIDERED A REPORTABLE ADVERSE EVENT BECAUSE CYSTS ARE A PERMANENT ALTERATION TO BODY STRUCTURE AND MEDICAL INTERVENTION IS REQUIRED TO CORRECT. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Cyst(s)

  MAUDE report 14602848 ↗
• InjuryOct 6, 2021Expulsion; Compatibility Problem; Expulsion; Compatibility Problem

  USER CONTACTED SUPPORT INDICATING THAT ON HER SECOND DAY OF USE WITH THE NEW CUP, DURING REMOVAL HER IUD CAME OUT WITH THE CUP. USER INTENDED TO SEEK MEDICAL TREATMENT FOR THE INSERTION OF A NEW IUD BUT OTHERWISE NO INJURIES/MEDICATIONS/INTERVENTIONS WERE REPORTED.

  Patient problems: Intermenstrual Bleeding; Menstrual Irregularities

  MAUDE report 12582761 ↗
• InjuryOct 6, 2021Expulsion; Compatibility Problem; Expulsion; Compatibility Problem

  USER CONTACTED SUPPORT INDICATING THAT AFTER INSERTING THE MENSTRUAL CUP THERE WAS A LOT OF PRESSURE SO THE USER IMMEDIATELY REMOVED THE CUP AND HER IUD CAME OUT WITH IT. FURTHER CONVERSATION WITH USER REVEALED THAT THEY NEVER CONSULTED THEIR OB/GYN PRIOR TO USE AS INDICATED ON LABELING. THE BRAND OF IUD INVOLVED WAS SKYLA. USER INTENDED TO SEEK MEDICAL TREATMENT FOR THE INSERTION OF A NEW IUD BUT OTHERWISE NO INJURIES/MEDICATIONS/INTERVENTIONS WERE NECESSARY.

  Patient problems: Intermenstrual Bleeding; Menstrual Irregularities

  MAUDE report 12582758 ↗
• InjuryMay 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  USER CONTACTED SUPPORT STATING THAT THEY HAD PROLAPSE SURGERY A YEAR AGO AND THEIR PROLAPSE HAD RECURRED AFTER USING THE MENSTRUAL CUP FOR ONE CYCLE. IT IS UNKNOWN IF THE PROLAPSE RECURRENCE WAS MEDICALLY INVESTIGATED AND/OR DIAGNOSED, OR IF THE CLAIMED RECURRED PROLAPSE WAS OF THE SAME TYPE AS THAT WHICH WAS REPAIRED PREVIOUSLY. SUPPORT ATTEMPTED TO SET UP A CALL WITH CUSTOMER TO DISCUSS DETAILS OF THE EVENT, THEIR REMOVAL METHOD, ETC. BUT THE CUSTOMER FAILED TO RESPOND TO FURTHER INQUIRY. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Prolapse

  MAUDE report 11777044 ↗