LoFric® Elle™ 4181450Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387024592), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.

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.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT OCCURRED IN THE USA. A FEMALE PATIENT WITH MULTIPLE SCLEROSIS HAS BEEN USING, SEVERAL STERILE, SINGLE-USE INTERMITTENT URINARY CATHETERS, LOFRIC ELLE (CH14). ON (B)(6) 2025, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED SHE HAD HAD SEVERAL URINARY TRACT INFECTIONS (UTI) AND THAT SEVERAL MONTHS EARLIER SHE ALSO HAD BEEN HOSPITALIZED DUE TO A UTI. THE MOST RECENT UTI OCCURRED LAST WEEK IN (B)(6). SINCE (B)(6) THE PATIENT IS DAILY TAKING ANTIBIOTIC 250MG KEFLEX. SHE FURTHER REPORTED THAT SHE STARTED CIC IN (B)(6) 2025 (DUE TO URINARY RETENTION, NEUROGENIC BLADDER) WITH LOFRIC ELLE AND DEVELOPED A UTI 2 WEEKS LATER. SHE SAW A DOCTOR, WAS HOSPITALIZED WITH CYSTITIS, URINE CULTURES WERE DONE, AND SHE HAD ANTIBIOTIC CIPRO FOR 3 DAYS AND THEN 2 DAYS OF ANOTHER ANTIBIOTIC. THEN SHE WAS SENT HOME WITH 5 DAYS CIPRO TO TAKE BY MOUTH. IN TOTAL THE PATIENT USED LOFRIC ELLE FOR 6 MONTHS. THE PATIENT IS NOW DOING WELL. THE PATIENT HAS CHOSEN TO NOW USE A DEVICE FROM ANOTHER MANUFACTURER. NONE OF THE DEVICES USED ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER, THE PATIENT THREW THEM ALL AWAY.

  Patient problems: Urinary Tract Infection

  MAUDE report 23013350 ↗