Lena LENA-CLR-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850008236082), received between May 1, 2020 and Jan 16, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REPORTED THAT SHE HAS EXPERIENCED A URINARY TRACT INFECTION WITH THE CUP USE. ANTIBIOTICS WERE USED TO TREAT THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11182846 ↗
• 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 WAS DIAGNOSED WITH BACTERIAL VAGINOSIS WHILE USING THE CUP. SHE VISITED HER PHYSICIAN WHO PRESCRIBED ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 10084739 ↗
• InjuryMay 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REPORTED THAT SHE HAS EXPERIENCED YEAST INFECTIONS OVER THE LAST YEAR. SHE DISCUSSED WITH PRIMARY CARE PHYSICIAN AND ALL OTHER TESTS ARE GOOD. SHE IS CONCERNED THAT THE CUP MAY BE CAUSING THE INFECTIONS BUT IT HAS NOT BEEN DIRECTLY LINKED TO THESE INFECTIONS.

  Patient problems: Fungal Infection

  MAUDE report 10018839 ↗