Lena LENA-GRN-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850008236037), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  USER REPORTED THAT SHE HAS EXPERIENCED URINARY TRACT INFECTIONS WITH THE CUP USE. SHE BELIEVES THAT WITH THE CUP IN PLACE SHE IS NOT ABLE TO EMPTY HER BLADDER, AND THIS CAUSED THE INFECTIONS. SHE HAS TAKEN ANTIBIOTICS EACH TIME TO RESOLVE THE ISSUE.

  Patient problems: Urinary Tract Infection

  MAUDE report 10722923 ↗