Lena LENA-PUR-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00850008236075), received between Aug 24, 2020 and Aug 12, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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.

• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem

  USER DESCRIBED EXTREME PAIN AND PUNCTURED SKIN. USER SOUGHT MEDICAL TREATMENT.

  Patient problems: Skin Tears

  MAUDE report 15221969 ↗
• InjuryFeb 11, 2022Difficult to Remove

  CUSTOMER REPORTED (B)(6) WAS UNABLE TO REMOVE THE CUP HERSELF AND SOUGHT MEDICAL ASSISTANCE.

  Patient problems: Genital Bleeding

  MAUDE report 13518712 ↗
• InjuryJun 16, 2021Difficult to Remove

  UNABLE TO REMOVE MENSTRUAL CUP, SHE SOUGHT MEDICAL INTERVENTION TO HELP REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009333 ↗
• MalfunctionFeb 7, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  USER REPORTED HAVING RECURRENT UTIS OVER THE LAST FEW MONTHS AND NOTICING A LOT MORE BLADDER IRRITATION/BLADDER PAIN OVERALL.

  Patient problems: Urinary Tract Infection

  MAUDE report 11290412 ↗
• MalfunctionJan 15, 2021Adverse Event Without Identified Device or Use Problem

  USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP AND VISITED URGENT CARE FOR HELP.SHE WAS ALSO PRESCRIBED ANTIBIOTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181315 ↗
• MalfunctionAug 24, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  USER REPORTED THAT HER IUD WAS DISLODGED WHILE REMOVING THE CUP. SHE DESCRIBED HAVING A HIGH CERVIX AND THAT THE CUP HAD MOVED UP AS SHE WAS SLEEPING. IT WAS BECOMING DIFFICULT TO REMOVE BECAUSE IT WAS HIGH UP AND ALTHOUGH SHE WAS BREAKING THE SEAL, SHE COULD NOT GET A GRIP ON THE CUP. AFTER SHE WAS ABLE TO, SHE PULLED THE CUP OUT AND FOUND THE IUD INSIDE. SHE HAS CONTACTED HER GYN AND HAS SCHEDULED AN APPOINTMENT TO DISCUSS HOW THIS MAY HAVE OCCURRED AND TO HAVE THE IUD REPLACED.

  Patient problems: Not Applicable

  MAUDE report 10443234 ↗