Lena LENA-RED-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850008236013), received between Nov 4, 2020 and Jul 7, 2022 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem

  THE USER DESCRIBED ITCHING AND PAIN AND SOUGHT MEDICAL TREATMENT. THE DOCTOR DIAGNOSED A URINARY TRACT INFECTION (UTI) AND PRESCRIBED ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 14950592 ↗
• MalfunctionNov 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  USER REPORTED LEAKING, EVEN THOUGH SHE WAS SURE THE CUP WAS INSERTED CORRECTLY. LENA CUP SENT HER A NEW LARGE CUP TO TRY, AS OPPOSED TO THE ONE SHE WAS PREVIOUSLY USING WHICH WAS A SMALL. SHE CONTINUED TO HAVE LEAKING, AND EXPERIENCED EXTREME PAIN WHEN USING THE CUP. AFTER VISITING HER GYN SHE WAS DIAGNOSED WITH A RETROVERTED UTERUS, WHICH WAS ALSO THE REASON WHY SHE HAD LEAKING.

  Patient problems: No Code Available; Pain

  MAUDE report 10788852 ↗