Lena LENA-MIXII-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850008236143), received between Jul 30, 2020 and Jun 16, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryJun 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  USER WENT TO URGENT CARE FOR ASSISTANCE REMOVING THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009301 ↗
• MalfunctionJan 15, 2021Device Dislodged or Dislocated

  USER REPORTED THAT HER IUD WAS DISLODGED WHILE REMOVING THE CUP. SHE NOTICED THE ELONGATION OF THE STRINGS UPON REMOVAL OF THE CUP AND THAT IT WAS VISIBLE AT THE INTROITUS. SHE CONTACTED HER MIDWIFE AND SCHEDULED AN APPOINTMENT TO HAVE THE IUD REPLACED.

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

  MAUDE report 11182381 ↗
• MalfunctionAug 30, 2020Difficult to Remove; Difficult to Remove

  USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP AND HAD TO VISIT PLANNED PARENTHOOD FOR ASSISTANCE TO HAVE IT REMOVED.

  Patient problems: Missing Value Reason; No Known Impact Or Consequence To Patient

  MAUDE report 10469802 ↗
• MalfunctionAug 24, 2020Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem; Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem

  USER REPORTED THAT SINCE USING THE CUPS FROM (B)(6) 2019 AND ONWARDS THAT SHE HAS NOTICED HAVING ISSUES WITH CONSTANT UTI'S AFTER EVERY PERIOD THAT SHE USED THEM. SHE HAS HAD TO VISIT HER PHYSICIAN FOR ANTIBIOTICS. SHE HAS ALSO HAD ISSUES WITH THE CUP INSERTION AND NOT OPENING COMPLETELY ONCE INSERTED, AS WELL AS HAVING A LOT OF PRESSURE ON HER BLADDER, MAKING IT FEEL LIKE SHE CAN'T EMPTY HER BLADDER COMPLETELY WHEN THE CUP IS INSERTED.

  Patient problems: Dysuria; Urinary Tract Infection

  MAUDE report 10445879 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER REPORTED THAT SHE EXPERIENCED TWO EPISODES OF SPOTTING WELL AFTER USING THE CUP. SHE IS WORKING WITH HER PHYSICIAN TO POSSIBLY DETERMINE THE CAUSE.

  Patient problems: Intermenstrual Bleeding; Menstrual Irregularities

  MAUDE report 10345871 ↗