Lena LENA-GRN-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850008236020), received between Apr 21, 2020 and Nov 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED THAT SHE TRIED TO USE THE CUP FOR 2 MENSTRUAL CYCLES AND BOTH TIMES, IT CAUSED HER EXTREME PAIN. SHE VISITED HER OBGYN TO SEE WHAT WAS THE CAUSE OF THE PROBLEM, BUT HER PHYSICAL WENT WELL, AND THEREFORE, SHE BELIEVES THAT THE CUP IS NOT A GOOD FIT FOR HER, AND SHE WILL NOT BE USING IT IN THE FUTURE.

  Patient problems: No Code Available; Pain

  MAUDE report 10806165 ↗
• MalfunctionOct 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP AND VISITED A DOCTOR FOR HELP. THE PHYSICIAN PRESCRIBED A SHORT COURSE OF ANTIBIOTICS AS A PRECAUTION BECAUSE THE CUP HADN'T BEEN REMOVED FOR OVER 2 DAYS. THE USER REPORTED FEELING FINE AFTER THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731878 ↗
• MalfunctionMay 23, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  USER REPORTED THAT SHE HAS EXPERIENCED URINARY TRACT INFECTIONS WITH THE CUP USE. SHE DISCUSSED WITH HER PHYSICIAN WHO ADVISED HER THAT WITH THE CUP IN PLACE SHE IS NOT ABLE TO EMPTY HER BLADDER AND THUS RESULTING IN THE INFECTIONS. THE PREVIOUS INCIDENT SHE HAD REPORTED WAS PRIOR TO THE LENA QMS IN 2019 AND THEREFORE IT HADN'T BEEN REPORTED. AT THE TIME SHE HAD ADVISED THAT SHE WAS PUT ON ANTIBIOTICS FOR THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10084738 ↗
• MalfunctionApr 21, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  USER REPORTED THAT SHE HAD TROUBLE REMOVING THE CUP AND VISITED HER GYNECOLOGIST FOR ASSISTANCE TO HAVE IT REMOVED.

  Patient problems: Abnormal Vaginal Discharge

  MAUDE report 9984345 ↗