Flex Reusable Menstrual Disc 10122Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00851906007590), received between Apr 1, 2023 and Jun 12, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (26 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Difficult to Remove; Patient Device Interaction Problem

  CUSTOMER REPORTED INABILITY TO REMOVE FLEX REUSABLE DISC AND WENT TO URGENT CARE FOR ASSISTANCE. THE CUSTOMER STATED THE DOCTOR HAD TO USE FORCEPS TO ASSIST WITH REMOVAL AND SHE WAS TOLD SHE HAD A HIGH CERVIX WHICH MAY HAVE AFFECTED REMOVAL. THE DISC HAD BEEN INSERTED FOR APPROXIMATELY 25 HOURS AT THE TIME OF MEDICAL REMOVAL. MEDICAL PERSONNEL STATED THAT THE CUSTOMER WOULD EXPERIENCE SOME INFLAMMATION AND SENSITIVITY FOLLOWING REMOVAL. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort

  MAUDE report 25491007 ↗
• MalfunctionMar 25, 2026Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED DIFFICULTY REMOVING THEIR FRD. THEY SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AND REPORTED DIFFICULTY WITH REMOVAL BECAUSE OF HOW HIGH THE DISC WAS POSITIONED. THE DISC TORE UPON REMOVAL AND TOOLS WERE NEEDED TO GRIP THE DISC IN ORDER TO FULLY REMOVE THE DISC. CUSTOMER REPORTED SORENESS, CRAMPING, AND VAGINAL SCRAPING FOLLOWING REMOVAL AS WELL AS NAUSEA FOR 2 DAYS. FLEX MADE THREE GOOD-FAITH EFFORTS TO FOLLOW UP WITH THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER FAILED TO RESPOND AND SO FLEX WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION REGARDING THIS COMPLAINT. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Abdominal Pain; Discomfort; Pain

  MAUDE report 24693836 ↗
• MalfunctionFeb 23, 2026Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER WAS UNABLE TO REMOVE THEIR FRD AND SOUGHT MEDICAL ASSISTANCE FROM OBGYN TO REMOVE THE DEVICE. THE CUSTOMER REPORTED THE DEVICE BROKE DURING REMOVAL - USE OF TOOLS WERE NEEDED TO REMOVE THE DEVICE, BUT REMOVAL WAS SUCCESSFUL. PRIOR TO REMOVAL, THE CUSTOMER EXPERIENCED PRESSURE AND BAD CRAMPS, BUT SYMPTOMS RESOLVED SHORTLY AFTER REMOVAL. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Genital Bleeding; Pain

  MAUDE report 24423026 ↗
• MalfunctionFeb 5, 2026Patient Device Interaction Problem

  THE CUSTOMER HAD TO HAVE THE DISC MEDICALLY REMOVED. THEY STATED THAT THE DISC HAD BEEN IN FOR 4 DAYS AND HAD STARTED TO GET UNCOMFORTABLE IN THEIR PELVIC AREA. THEY REPORTED FEELING CRAMPING, PAIN/DISCOMFORT, AND INFLAMMATION. NO MEDICATION WAS PRESCRIBED AND SYMPTOMS RESOLVED AFTER REMOVAL OF THE PRODUCT. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Inflammation; Pain

  MAUDE report 24269301 ↗
• MalfunctionOct 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED DIFFICULTY REMOVING MEDICAL DEVICE AND EXPERIENCED CRAMPING SEVERAL HOURS PRIOR TO REMOVAL. THEY SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AND NEEDED TO USE MEDICAL INSTRUMENTS FOR REMOVAL. DURING THE REMOVAL PROCESS, THE DISC PORTION BROKE UNDER THE PRESSURE OF CLAMPS. THE HARDER RIM AND RETAINED DISC PORTION REMAINED STUCK, REQUIRING FURTHER INTERVENTION TO RESOLVE. THE CUSTOMER REPORTED MILD VAGINAL PAIN AND DISCOMFORT DUE TO SEVERAL REMOVAL ATTEMPTS USING INSTRUMENTATION. THEY ALSO REPORTED EXPERIENCING CERVICAL BLEEDING AND PAIN DUE TO INSTRUMENTATION, NAUSEA, LIGHTHEADEDNESS, ODOR, INFLAMMATION, TEAR/LACERATION/OTHER INJURY, AND PRESSURE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Abdominal Pain; Discomfort; Genital Bleeding; Inflammation; Laceration(s)

  MAUDE report 23372223 ↗
• MalfunctionOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER ATTEMPTED TO USE THE DISC MULTIPLE TIMES, BUT REPORTED EXPERIENCING THE SAME ITCHING/BURNING SENSATION FROM USING THEM. INITIALLY, THE CUSTOMER THOUGHT IT WAS A YEAST INFECTION AND STARTED MONISTAT, BUT AFTER SEEKING MEDICAL ATTENTION, THE VAGINAL SWABS WERE NEGATIVE FOR YEAST AND BV. THEIR HEALTH PROVIDER PRESCRIBED FLUCONAZOLE, WHICH HELPED TO RESOLVE THEIR SYMPTOMS. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Burning Sensation; Itching Sensation

  MAUDE report 23318540 ↗
• MalfunctionSep 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED THAT THEIR FLEX REUSABLE DISC BECAME STUCK AND AFTER SEVERAL UNSUCCESSFUL ATTEMPTS AT REMOVING THE DISC THEMSELVES, THEY HAD TO GO TO URGENT CARE TO HAVE IT REMOVED. THE DISC WAS IN FOR 16HRS PRIOR TO REMOVAL. CUSTOMER REPORTED PAIN WHEN TRYING TO REMOVE DISC (NOTING THAT IT WAS REMOVAL ITSELF CAUSING PAIN RATHER THAN DEVICE ITSELF), THAT A TOOL WAS USED TO REMOVE THE DISC, AND THAT THE DEVICE WAS DISCARDED. CUSTOMER WAS NOT PRESCRIBED ANY MEDICATION AND REPORTED THAT SYMPTOMS RESOLVED AFTER REMOVAL OF DEVICE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 23077278 ↗
• MalfunctionAug 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED EXPERIENCING VAGINAL TRAUMA, ALONG WITH A BURNING SENSATION AND ITCHING, WHEN REMOVING A REUSABLE MENSTRUAL DISC. CUSTOMER ALSO REPORTED SWELLING, PAIN/DISCOMFORT, AND INFLAMMATION. CUSTOMER STATED THAT THEY DID NOT HAVE ANY ISSUES WHEN USING AND REMOVING DEVICE DURING PRIOR MENSTRUAL CYCLES. CUSTOMER SOUGHT MEDICAL HELP AND WAS PRESCRIBED GINENORM AND TERJINAN. SYMPTOMS RESOLVED AFTER 5-6 DAYS (2 DAYS OF MEDICATION). THE CUSTOMER WAS ADVISED TO DISCONTINUE THEIR USE OF THE REUSABLE DEVICES AND FOLLOW THE INSTRUCTIONS OF THEIR MEDICAL PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Itching Sensation; Pain; Swelling/ Edema

  MAUDE report 22891759 ↗
• MalfunctionAug 19, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  CUSTOMER REPORTED SEEKING MEDICAL ASSISTANCE FROM THEIR OBGYN FOR THE REMOVAL OF A REUSABLE FLEX DISC. CUSTOMER STATED THE DISC HAD BEEN IN PLACE FOR APPROXIMATELY 16 HOURS AT TIME OF REMOVAL. THE CUSTOMER STATED THE DOCTOR USED TOOLS TO ASSIST WITH REMOVAL BUT DID NOT SPECIFY WHICH. CUSTOMER REPORTED SOME PAIN/DISCOMFORT DUE TO THE EXPERIENCE, BUT DID NOT HAVE ANY SERIOUS ADVERSE SYMPTOMS - CUSTOMER STATED PAIN/DISCOMFORT RESOLVED IMMEDIATELY AFTER PRODUCT REMOVAL AND WAS NOT PRESCRIBED ANY MEDICATION BY THEIR DOCTOR. CUSTOMER REPORTED THAT THE OBGYN STATED THEY HAVE A HIGH CERVIX AND A MENSTRUAL CUP WOULD BE A BETTER PRODUCT FOR THEIR ANATOMY. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 22842952 ↗
• MalfunctionJul 29, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE REUSABLE MENSTRUAL DISC COULD NOT BE REMOVED BY THE CUSTOMER. THE CUSTOMER WENT TO THE EMERGENCY ROOM TO HAVE IT REMOVED. CUSTOMER REPORTED TOOLS WERE USED FOR REMOVAL AND THAT THEY EXPERIENCED PAIN. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 22644566 ↗
• MalfunctionJul 7, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE REUSABLE MENSTRUAL DISC COULD NOT BE REMOVED BY THE CUSTOMER. THE CUSTOMER WENT TO THE EMERGENCY ROOM TO HAVE IT REMOVED. CUSTOMER REPORTED TOOLS WERE USED FOR REMOVAL AND THAT THEY EXPERIENCED PAIN. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 22414855 ↗
• MalfunctionJun 30, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE REUSABLE MENSTRUAL DISC GOT LODGED IN A WAY THAT THEY COULD NOT REMOVE. CUSTOMER WENT TO THE EMERGENCY ROOM TO HAVE THE DISC REMOVED BY A MEDICAL PROFESSIONAL. CUSTOMER STATED THEY EXPERIENCED PAIN. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 22355280 ↗
• MalfunctionDec 13, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER WENT TO THE ER FOR ASSISTANCE WITH REMOVAL OF FLEX REUSABLE DISC THAT HAD BEEN INSERTED FOR APPROXIMATELY 30 HOURS. THE CUSTOMER REPORTED HAVING A HEADACHE AND FEELING ANXIOUS AND LIGHTHEADED. THE CUSTOMER STATED THAT IT TOOK THE DOCTOR APPROXIMATELY 30 MINUTES AND "A BROKEN PAIR OF FORCEPS" BEFORE THE FLEX REUSABLE DISC WAS SUCCESSFULLY REMOVED. THE CUSTOMER ALSO STATED THAT THE DOCTOR SAID THE DISC WAS LIKE A "TOURNIQUET ON HER CERVIX" AND THE DISC WAS BROKEN DURING MEDICAL REMOVAL. CUSTOMER REPORTED AN INTERNAL LACERATION FROM MEDICAL REMOVAL AS WELL. THE DOCTOR ADVISED THE CUSTOMER TO TAKE TYLENOL FOR PAIN AND DISCOMFORT. THE CUSTOMER STATED SHE WAS SORE POST REMOVAL AND TYLENOL DID NOT HELP. SYMPTOMS DID RESOLVE AFTER A FEW DAYS. THE CUSTOMER WAS ADVISED BY THE DOCTOR AND BY FLEX TO FOLLOW UP WITH THEIR PRIMARY HEALTHCARE PROVIDER TO DISCUSS THEIR EXPERIENCE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Discomfort; Laceration(s); Pain

  MAUDE report 20932105 ↗
• MalfunctionOct 18, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA SMS TO REPORT THAT THEY WERE EXPERIENCING CRAMPING AND HAVING DIFFICULTY REMOVING THEIR FLEX REUSABLE DISC. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER USED A SPECULUM AND FORCEPS TO REMOVE THE DEVICE. DEVICE HAD BEEN INSERTED FOR APPROXIMATELY 19 HOURS AT TIME OF REMOVAL. THE CUSTOMER REPORTED INCREASED CRAMPING POST REMOVAL BUT DID NOT REPORT ANY OTHER ADVERSE SYMPTOMS BEFORE, DURING, OR AFTER REMOVAL OF THE DEVICE. THE COMPANY ADVISED THE CUSTOMER TO FOLLOW THE INSTRUCTIONS OF THEIR TREATING PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482526 ↗
• MalfunctionSep 12, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA PHONE AND SMS TEXT MESSAGING TO REPORT THAT THEY WERE EXPERIENCING DIFFICULTY REMOVING THE DEVICE AND THAT THE DEVICE HAD BEEN IN PLACE FOR APPROXIMATELY 24 HOURS. THE CUSTOMER WAS ADVISED BY THE COMPANY'S CUSTOMER EXPERIENCE TEAM TO SEEK MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL URGENT CARE. THIS WAS THE FIRST TIME THE CUSTOMER HAD USED THE DEVICE, AND IT HAD BEEN IN PLACE FOR APPROXIMATELY 33 HOURS BY THE TIME THEY SOUGHT ASSISTANCE TO HAVE THE DEVICE REMOVED. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER ENCOUNTERED SOME DIFFICULTY AND HAD TO USE A SPECULUM AND FORCEPS TO REMOVE THE DEVICE. THE CUSTOMER ALSO STATED THAT IT TOOK APPROXIMATELY 20 MINUTES TO REMOVE THE DEVICE, WHICH BROKE DURING THE REMOVAL PROCESS. THE CUSTOMER STATED THAT THEY EXPERIENCED SOME PAIN DURING REMOVAL, BUT DID NOT REPORT EXPERIENCING ANY OTHER ADVERSE SYMPTOMS BEFORE, DURIN, OR AFTER REMOVAL OF THE DEVICE. THE COMPANY ADVISED THE CUSTOMER TO FOLLOW THE INSTRUCTIONS OF THEIR TREATING PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER E

  Patient problems: Pain

  MAUDE report 20208380 ↗
• MalfunctionAug 15, 2024Device-Device Incompatibility; Patient Device Interaction Problem; Device-Device Incompatibility; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA SMS TEXT MESSAGING TO REPORT THAT THEIR USE OF THE DEVICE CAUSED SIGNIFICANT CRAMPING AND MADE THEIR IUD "DESCEND". THE CUSTOMER STATED THAT THEY SUBSEQUENTLY HAD TO HAVE THE IUD REMOVED. THE COMPANY MADE THREE GOOD-FAITH EFFORTS TO FOLLOW UP WITH THE CUSTOMER IA EMAIL IN ORDER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER FAILED TO RESPOND. THE INSTRUCTIONS FOR USE THAT ARE PROVIDED IN THE PACKAGING WITH THE DEVICE STATES "CONSULT YOUR DOCTOR IF YOU ARE USING AN INTRAUTERINE DEVICE (IUD). WHILE UNCOMMON, THERE IS A RISK OF DISLODGING, DISPLACING, OR REMOVING THE IUD BY PULLING ON THE IUD STRING WHEN REMOVING FLEX REUSABLE DISC." THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 19997200 ↗
• MalfunctionJul 12, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA SMS TEXT MESSAGING TO REPORT THAT THEY HAD EXPERIENCED DIFFICULTY REMOVING THE DEVICE, AND HAD SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL EMERGENCY ROOM. THIS WAS THE FIRST TIME THE CUSTOMER HAD USED THE DEVICE, AND IT HAD BEEN IN PLACE FOR APPROXIMATELY 24 HOURS BEFORE THEY SOUGHT ASSISTANCE. THE COMPANY MADE THREE GOOD-FAITH EFFORTS TO FOLLOW UP WITH THE CUSTOMER VIA EMAIL IN ORDER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER FAILED TO RESPOND. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735034 ↗
• MalfunctionJul 3, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT THAT THEY HAD EXPERIENCED DIFFICULTY REMOVING THE DEVICE, AND HAD SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL URGENT CARE. THIS WAS THE FIRST TIME THE CUSTOMER HAD USED THE DEVICE, AND IT HAD BEEN IN PLACE FOR APPROXIMATELY TWO DAYS BEFORE THEY SOUGHT ASSISTANCE. THE CUSTOMER STATED THAT THEY COULD FEEL THE DEVICE BUT COULD NOT HOOK THEIR FINGER ON THE RIM TO REMOVE IT. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER AT THE URGENT CARE TRIED FOR APPROXIMATELY 10 MINUTES TO REMOVE THE DEVICE WITHOUT SUCCESS. THE PROVIDER ADVISED THE CUSTOMER TO MAKE AN APPOINTMENT AT ANOTHER URGENT CARE FACILITY FOR LATER THAT DAY, WHICH THE CUSTOMER DID. THE TREATING PROVIDER AT THE SECOND URGENT CARE WAS ABLE TO SUCCESSFULLY REMOVE THE DEVICE WITH THE USE OF A SPECULUM AND FORCEPS. THE CUSTOMER REPORTED EXPERIENCING SOME CRAMPING PRIOR TO REMOVAL, BUT DID NOT REPORT ANY OTHER ADVERSE SYMPTOMS DURING OR AFTER REMOVAL OF THE DEVICE. THE COMPANY ADVISED THE CUSTOMER TO FOLLOW THE INSTRUCTIONS OF THEIR TREATING PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672236 ↗
• InjuryJun 18, 2024Device-Device Incompatibility; Patient Device Interaction Problem; Device-Device Incompatibility; Patient Device Interaction Problem

  THE CUSTOMER LEFT A REVIEW ON THE COMPANY'S WEBSITE TO REPORT THAT THEY HAD BEEN USING THE DEVICE FOR APPROXIMATELY TWO MONTHS WHEN THEY DISCOVERED THEIR IUD WAS DISPLACED AND THEY HAD BECOME PREGNANT. THE COMPANY FOLLOWED UP WITH THE CUSTOMER VIA EMAIL. THE CUSTOMER RESPONDED, STATING THAT THEY WERE UNAWARE AT THE TIME OF DISPLACEMENT, BUT LATER CHECKED THEIR IUD STRINGS AND FELT THAT THEY WERE LOWER THAN USUAL. THE CUSTOMER STATED THEY WERE NOT EXPERIENCING THEIR "USUAL CONSISTENT PMS SYMPTOMS", SO THEY TOOK A PREGNANCY TEST WHICH CAME BACK POSITIVE. ULTRASOUND IMAGING WAS PERFORMED AT A PLANNED PARENTHOOD FACILITY WHERE THE CUSTOMER SAYS IT WAS CONFIRMED THAT THE IUD HAD MOVED TO A LOWER POSITION "REDUCING ITS EFFECTIVENESS". THE CUSTOMER STATES THEY HAD THEIR IUD REMOVED. THE CUSTOMER DENIED EXPERIENCING ANY ADVERSE SYMPTOMS DURING OR AFTER THE PROCEDURE. THE CUSTOMER WAS ADVISED BY THE COMPANY THAT THE INSTRUCTIONS FOR USE THAT ARE PROVIDED IN THE PACKAGING WITH THE DEVICE STATE "CONSULT YOUR DOCTOR IF YOU ARE USING AN INTRAUTERINE DEVICE (IUD). WHILE UNCOMMON, THERE IS A RISK OF DISLODGING, DISPLACING, OR REMOVING THE IUD BY PULLING ON THE IUD STRING WHEN REMOVING FLEX REUSAB

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19560071 ↗
• MalfunctionApr 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA SMS TEXT TO REPORT THAT THIS WAS THEIR FIRST TIME USING THE DEVICE AND THEY WERE HAVING DIFFICULTY REMOVING IT. THE COMPANY'S CUSTOMER EXPERIENCE TEAM PROVIDED LIVE ASSISTANCE, HOWEVER, THE CUSTOMER WAS AT WORK AND STATED THAT THEY WOULD NEED TO TRY THE TIPS PROVIDED ONCE THEY WERE HOME LATER THAT EVENING/AFTER HOURS. THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA LIVE CHAT THE FOLLOWING MORNING AND STATED THAT THEY HAD SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL EMERGENCY ROOM. THE CUSTOMER STATED THAT THE DEVICE WAS IN PLACE FOR APPROXIMATELY 25 HOURS BEFORE BEING REMOVED AND THEIR TREATING PROVIDER INFORMED THEM DURING REMOVAL THAT IT WAS "TWISTED" AND THERE WAS SOME SUCTION, BUT THEY WERE ABLE TO REMOVE THE DEVICE DIGITALLY WITHOUT THE USE OF ANY TOOLS. THE CUSTOMER REPORTED EXPERIENCING SOME DISCOMFORT AND PRESSURE DURING REMOVAL, BUT DID NOT REPORT EXPERIENCING ANY OTHER ADVERSE SYMPTOMS DURING OR AFTER REMOVAL OF THE DEVICE. THE COMPANY ADVISED THE CUSTOMER TO DISCONTINUE THEIR USE OF THE DEVICE AND FOLLOW THE INSTRUCTIONS OF THEIR TREATING PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19188617 ↗
• MalfunctionApr 4, 2024Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE FLEX COMPANY'S CUSTOMER SERVICE TEAM FOR ASSISTANCE AFTER HAVING SOME DIFFICULTY REMOVING A DISPOSABLE FLEX DISC AND WAS ADVISED TO SEEK MEDICAL ASSISTANCE. THIS WAS THE CUSTOMER'S FIRST CYCLE USING A MENSTRUAL DISC AND THE DISC HAD BEEN INSERTED FOR 16 HOURS AT TIME OF REMOVAL. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER UTILIZED A SPECULUM, EXPERIENCED DIFFICULTY REMOVING THE DEVICE, AND COMMENTED THAT THE DEVICE WAS SUCTIONED ONTO THE CERVIX. THE CUSTOMER REPORTED EXPERIENCING PAIN DURING REMOVAL AND SLIGHT BRUISING FOLLOWING REMOVAL. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 19042419 ↗
• MalfunctionSep 21, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL AND STATED THAT THEY WERE EXPERIENCING DIFFICULTY REMOVING THE DEVICE. THE COMPANY'S CUSTOMER EXPERIENCE TEAM FOLLOWED UP VIA EMAIL WITH REMOVAL TIPS AND ADVICE, AND THE NEXT DAY THE CUSTOMER RESPONDED STATING THAT THEY WERE UNABLE TO REMOVE THE DEVICE ON THEIR OWN AND HAD TO GO TO THEIR DOCTORS FOR ASSISTANCE THAT MORNING. THIS WAS THE FIRST TIME THE CUSTOMER HAD USED THE DEVICE AND STATED THAT IT WAS IN PLACE FOR APPROXIMATELY 16 HOURS BEFORE THEY WERE ABLE TO GET IT REMOVED. THE CUSTOMER HAD TRIED MULTIPLE REMOVAL TECHNIQUES AS WELL AS OBTAINING ASSISTANCE FROM THEIR HUSBAND BUT WERE NOT SUCCESSFUL. THE CUSTOMER WENT TO A WALK-IN CLINIC FOR ASSISTANCE WITH REMOVAL. A NURSE PRACTITIONER EXPERIENCED DIFFICULTY REMOVING THE DEVICE BUT EVENTUALLY REMOVED IT SUCCESSFULLY WITH FORCEPS. NO ADVERSE SYMPTOMS WERE REPORTED BY EITHER THE CUSTOMER OR THE MEDICAL PROVIDER DURING OR AFTER REMOVAL OF THE DEVICE. THE CUSTOMER WAS ADVISED TO DISCONTINUE THEIR USE OF THE DEVICE AND FOLLOW UP WITH THEIR PRIMARY CARE PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795638 ↗
• MalfunctionAug 3, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED TEH COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT THAT THEY EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT AN EMERGENCY ROOM. THE CUSTOMER DID NOT INDICATE HOW LONG THE DEVICE HAD BEEN IN PLACE PRIOR TO REMOVAL. THE EVENT OCCURRED THE FIRST TIME THE CUSTOMER USED THE DEVICE. THE PHYSICIAN INFORMED THE CUSTOMER THAT THEY HAD A TILTED AND VERY HIGH CERVIX. THE CUSTOMER INDICATED THAT THE PHYSICIAN HAD TO USE TOOLS TO REMOVE THE DEVICE AND HAD A DIFFICULT TIME. THE CUSTOMER REPORTED PAIN DURING THE REMOVAL PROCESS. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17456121 ↗
• MalfunctionJul 14, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA TEXT MESSAGE TO REPORT THAT THEY WERE EXPERIENCING DIFFICULTY REMOVING THE DEVICE AFTER INSERTING IT OVER 24 HOURS BEFORE. THE EVENT OCCURRED THE FIRST TIME THE CUSTOMER USED THE DEVICE. THE COMPANY'S CUSTOMER EXPERIENCE TEAM PROVIDED LIVE TEXT ASSISTANCE FOR TWO HOURS, BUT THE CUSTOMER WAS STILL UNABLE TO SUCCESSFULLY REMOVE THE DEVICE, SO THEY WERE ADVISED TO SEEK MEDICAL ASSISTANCE FOR REMOVAL AT AN URGENT CARE CENTER. THE COMPANY'S CUSTOMER EXPERIENCE TEAM FOLLOWED UP WITH THE CUSTOMER THE NEXT MORNING, AND THE CUSTOMER CONFIRMED THAT THEY WENT TO AN URGENT CARE CENTER WHERE THE DEVICE WAS SUCCESSFULLY REMOVED BY A DOCTOR. THE CUSTOMER REPORTED NO ADVERSE SYMPTOMS FOLLOWING THE PROCEDURE. THE COMPANY MADE THREE ADDITIONAL GOOD-FAITH EFFORTS TO FOLLOW UP WITH THE CUSTOMER VIA EMAIL IN ORDER TO OBTAIN ADDITIONAL INFORMATION FOR OUR INVESTIGATION, HOWEVER, THE CUSTOMER FAILED TO RESPOND. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17330420 ↗
• MalfunctionJul 5, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT THAT THEY EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT AN URGENT CARE CENTER. THE URGENT CARE PHYSICIAN NOTED THAT THEY ATTEMPTED TO REMOVE THE DEVICE WITH MULTIPLE DIFFERENT TOOLS BECAUSE THE DEVICE HAD ACHIEVED SUCTION AROUND THE CERVIX. THE CUSTOMER EXPERIENCED SOME MILD DISCOMFORT DURING THE PROCEDURE, BUT NO ADVERSE SYMPTOMS WERE REPORTED BY EITHER THE CUSTOMER OR THE PHYSICIAN AFTER REMOVAL OF THE DEVICE. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17263326 ↗