Flex Cup and Flex Disc Flex Discovery Kit Slim FitRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851906007262), received between Mar 13, 2023 and Apr 5, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE FLEX COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL STATING THAT THEY HAD EXPERIENCED A LOCALIZED ALLERGIC REACTION WHILE USING THE DEVICE IN EARLY (B)(6) 2023. THIS WAS THE CUSTOMER'S FIRST TIME USING THE DEVICE. THE CUSTOMER STATED THAT WITHIN APPROXIMATELY ONE TO TWO HOURS OF INSERTING THE DEVICE THEY BEGAN TO EXPERIENCE LOCALIZED PAIN, SWELLING, AND A BURNING SENSATION. THE CUSTOMER PROMPTLY REMOVED THE DEVICE, WHICH DID NOT ALLEVIATE THEIR SYMPTOMS, SO THEY SOUGHT EVALUATION AND TREATMENT AT A LOCAL URGENT CARE. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER PRESCRIBED A COURSE OF PREDNISONE, AND THAT THEIR SYMPTOMS WERE COMPLETELY RESOLVED AFTER APPROXIMATELY THREE DAYS. THE CUSTOMER HAS A KNOWN ALLERGY TO LATEX. THE CUSTOMER DID NOT REPORT ANY LINGERING SYMPTOMS OR ISSUES FOLLOWING THE EVENT. 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 AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 19055906 ↗
• MalfunctionFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT THAT THEY BELIEVE THEY HAVE AN ALLERGY TO SILICONE AFTER USING THE DEVICE FOR THE FIRST TIME. THE CUSTOMER REPORTED HAVING EXTENSIVE KNOWN ALLERGIES/SENSITIVITIES, INCLUDING BENADRYL, CONCERTA, LUVOX, MUCINEX DM, PREDNISONE, RITALIN, TEGRETOL, TOSYMRA, TRIAMCINOLONE, MOMETASONE, BLUE STAR ANTI-ITCH OINTMENT, MICELLAR WATER, MOST DEODORANTS, MOST LUBRICANTS, COSTUME MAKEUP, ADHESIVES, LATEX, NICKEL, HEAT, DAWN DISH DETERGENT, TIDE LAUNDRY DETERGENT, CANTALOUPE, MANGO, SHELLFISH, AND GOAT'S MILK. AS A RESULT OF THE CUSTOMER'S MULTIPLE ALLERGIES, THEY TAKE A REGULAR DOSE OF 360MG OF ALLEGRA TWICE A DAY. AFTER USING THE DEVICE OVER THE COURSE OF TWO DAYS THE CUSTOMER REPORTED EXPERIENCING PAIN, ITCHING, AND HIVES ON THEIR VAGINA, VULVA, AND INNER THIGHS WITHIN A FEW HOURS AFTER INSERTING THE DEVICE. THE CUSTOMER FURTHER REPORTED THAT THEIR SYMPTOMS RESOLVED A FEW HOURS AFTER REMOVING THE DEVICE, AND THAT THEY DID NOT SEEK MEDICAL EVALUATION OR TREATMENT. THE CUSTOMER STATED THAT THEY HAD "EXPERIENCED ALLERGIC REACTIONS TO MEDICATIONS IN THAT AREA PREVIOUSLY AND KNEW HOW TO HANDLE IT" AND THAT THEIR SYMPTO

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Urticaria

  MAUDE report 18636106 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER LEFT A REVIEW ON THE COMPANY'S WEBSITE TO REPORT THAT THEY HAD BEEN ADMITTED TO THE HOSPITAL FOR IR DRAINAGE OF A TUBO-OVARIAN ABSCESS (TOA) AFTER EXPERIENCING FOUR DAYS OF FEVER AND ABDOMINAL/PELVIC PAIN. THE CUSTOMER WAS DIAGNOSED WITH A LARGE LEFT TOA AND IR DRAINAGE WAS PERFORMED ON THEIR DATE OF ADMISSION. DAILY LAB WORK WAS DRAWN, AND THE CUSTOMER RECEIVED IV ANTIBIOTICS FOR THREE DAYS WHILE IN THE HOSPITAL. THE CUSTOMER WAS PRESCRIBED ADDITIONAL ANTIBIOTICS AFTER DISCHARGE TO COMPLETE A 14-DAY COURSE, AND THE DRAIN WAS REMOVED ON (B)(6) 2023. THE CUSTOMER DID NOT REPORT EXPERIENCING ANY ADVERSE SYMPTOMS OR OTHER ISSUES AFTER DISCHARGE FROM THE HOSPITAL. THE CUSTOMER ALLEGED THAT THEIR INFECTION AND TOA WERE LINKED TO THEIR MENSTRUAL CUP USE. ALTHOUGH THE CUSTOMER CLAIMS THEY HAD BEEN USING THE DEVICE FOR APPROXIMATELY FOUR MONTHS WITHOUT ISSUE BEFORE THE INCIDENT, NO INFORMATION WAS PROVIDED REGARDING TIMING OF THE USE OF THE DEVICE BEFORE THE ONSET OF SYMPTOMS. IN ADDITION, THE LIMITED MEDICAL RECORDS PROVIDED BY THE CUSTOMER DO NOT MENTION THE DEVICE OR ANY OTHER SOURCE OF THE INFECTION. FINALLY, BASED ON A SURVEY OF PUBLICLY AVAILABLE RESEARCH, TOA IS MOST CO

  Patient problems: Abdominal Pain; Abscess; Bacterial Infection; Fever

  MAUDE report 18297947 ↗
• 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 PHONE AND LEFT A VOICEMAIL STATING THAT THEY WERE HAVING DIFFICULTY REMOVING THEIR FLEX CUP. A CUSTOMER EXPERIENCE AGENT CALLED THE CUSTOMER BACK WITHIN 30 MINUTES AND PROVIDED LIVE ASSISTANCE FOR APPROXIMATELY 20 MINUTES. THE CUSTOMER STATED THAT THEY BELIEVED THE CUP HAD FLIPPED UPSIDE DOWN AS THEY COULD NOT FEEL THE PULL TAB AND COULD FEEL THE INSIDE OF THE CUP. THIS WAS THE FIRST TIME THE CUSTOMER HAD USED THE DEVICE. THE CUSTOMER INDICATED THAT THEY MIGHT SEEK MEDICAL ASSISTANCE FOR REMOVAL IF THEY WERE UNABLE TO REMOVE THE PRODUCT ON THEIR OWN AND REQUESTED EMAIL FOLLOW UP. THE COMPANY'S CUSTOMER EXPERIENCE TEAM FOLLOWED UP WITH THE CUSTOMER VIA EMAIL THE NEXT MORNING TO SEE IF THEY WERE ABLE TO REMOVE THE DEVICE OR IF THEY SOUGHT MEDICAL ASSISTANCE. THE CUSTOMER RESPONDED THE FOLLOWING DAY STATING THAT THEY DID OBTAIN A SAME-DAY APPOINTMENT AT A CLINIC WHERE THE DEVICE WAS SUCCESSFULLY REMOVED. THE CUSTOMER STATED THAT THE REMOVAL WAS DIFFICULT AND PAINFUL, AND BELIEVED THE CUP WAS "FACING DOWNWARDS" AND "STUCK". THE CUSTOMER WAS ADVISED TO DISCONTINUE THEIR USE OF THE DEVICE AND FOLLOW UP WITH THEIR PRIMARY C

  Patient problems: Pain

  MAUDE report 17795146 ↗
• 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 EMAIL TO REPORT THAT THEY WERE EXPERIENCING DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AFTER IT HAD BEEN IN PLACE FOR APPROXIMATELY 20 HOURS. THE EVENT OCCURRED THE FIRST TIME THE CUSTOMER USED THE DEVICE. THE CUSTOMER STATED THAT THEY HAD SEXUAL INTERCOURSE WHILE THE DEVICE WAS INSERTED, AND THAT THEY TRIED TO REMOVE THE DEVICE FOR APPROXIMATELY EIGHT HOURS BEFORE SEEKING MEDICAL ASSISTANCE AT AN URGENT CARE CENTER. THE CUSTOMER STATED THAT THE NURSE PRACTITIONER AT THE URGENT CARE ENCOUNTERED SOME DIFFICULTY REMOVING THE DEVICE, BUT THEY WERE EVENTUALLY ABLE TO SUCCESSFULLY REMOVE THE DEVICE. THE CUSTOMER STATED THAT THE DEVICE BROKE WHEN IT WAS REMOVED, HOWEVER, NO ADVERSE SYMPTOMS WERE REPORTED BY EITHER THE CUSTOMER OR THE NURSE PRACTITIONER 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 17330438 ↗
• MalfunctionMar 13, 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 WERE HAVING DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE TO ASSIST WITH REMOVAL. THE EVENT OCCURRED THE FIRST TIME THE CUSTOMER USED THE DEVICE. THE CUSTOMER STATED THAT THEY FOLLOWED THE INSTRUCTIONS ON THE PACKAGE LABELING FOR INSERTION AND REMOVAL. THE CUSTOMER FURTHER STATED THAT UPON INSERTION, THE STEM RETREATED BACK INSIDE OF THE DEVICE. THEY TRIED FOR TWO HOURS BUT WERE UNABLE TO REMOVE THE DEVICE TO CORRECT THE ISSUE, SO THEY SOUGHT MEDICAL ASSISTANCE. THE CUSTOMER STATED THAT THEY DID NOT HAVE INTERCOURSE WITH THE DEVICE INSERTED, NOR WERE THEY AWARE OF ANY PHYSICAL NUANCES THAT WOULD HAVE CONTRIBUTED TO THE DIFFICULT REMOVAL. THE CUSTOMER STATED THAT THE NURSE PRACTITIONER WAS UNABLE TO REMOVE THE DEVICE USING A SPECULUM AS A VISUAL AID; SUBSEQUENTLY, THEY STATE IT TOOK A PHYSICIAN 4 ATTEMPTS TO REMOVE THE DEVICE. THIS DEVICE IS DESIGNED SO THAT IT CAN BE REMOVED WITH A PULL-TAB BUT MAY ALSO BE REMOVED LIKE A TRADITIONAL MENSTRUAL CUP WITHOUT THE PULL-TAB. PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE "IF THE PULL-TAB IS NOT WORKING, FLEX CUP CAN BE REMOVED

  Patient problems: Foreign Body In Patient

  MAUDE report 16529852 ↗