Lena LENA-RED-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850008236006), received between Sep 25, 2020 and Sep 27, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 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.

• InjurySep 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REPORTED HAVING YEAST INFECTIONS FOR THREE MONTHS AROUND HER PERIOD AND VISITED HER DOCTOR FOR MEDICATION.

  Patient problems: Abnormal Vaginal Discharge

  MAUDE report 15495362 ↗
• MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  USER REPORTED HAVING TO VISIT THE ER BECAUSE HER IUD HAD BEEN DISLODGED. SHE WAS ALSO PRESCRIBED ANTIBIOTICS FOR A BLADDER INFECTION WHICH SHE BELIEVED TO BE FROM THE CUP NOT ALLOWING HER TO FULLY EMPTY HER BLADDER.

  Patient problems: Urinary Tract Infection

  MAUDE report 11355799 ↗
• MalfunctionJan 17, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REPORTED DIFFICULTY IN REMOVING THE CUP THAT LED TO UTI WHICH WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 11183158 ↗
• MalfunctionNov 11, 2020Difficult to Remove; Difficult to Remove

  CUSTOMER REPORTED THAT AFTER USING THE CUP FOR 2.5 DAYS IT APPEARED TO BE LODGED AND SHE WAS NOT ABLE TO REMOVE IT. APPROXIMATELY 48 HOURS LATER SHE STARTED TO FEEL LETHARGIC AND NOTICED SPOTTING AGAIN. SHE ONCE AGAIN TRIED TO REMOVE THE CUP AND WAS ABLE TO THIS TIME. SHE THEN EXPERIENCED DISCHARGE AND SMELL FOR ALMOST 2.5 WEEKS THAT REQUIRED TREATMENT TO RESOLVE.

  Patient problems: Abnormal Vaginal Discharge

  MAUDE report 10826162 ↗
• MalfunctionSep 25, 2020Difficult to Remove; Difficult to Remove

  USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP, AND HAD TO VISIT BOTH HER PRIMARY CARE PHYSICIAN AND HER GYNECOLOGIST TO HAVE IT REMOVED.

  Patient problems: No Code Available

  MAUDE report 10589272 ↗