CURE ULTRA MALE CATHETER ULTRA M10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947021045), received between Sep 28, 2022 and Sep 28, 2022 — 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 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER STATES HE GOT A UTI WHILE USING AN EXPIRED BOX OF THE ULTRAM10 CATHETERS - 1 MU, QTY 30 CATHETERS, LOT # 190616-3. HE SAID HE DIDN'T REALLY PAY ATTENTION WHEN HE GRABBED THIS BOX OF CATHETERS FROM HIS STORAGE AND HE SAID HE USED THE WHOLE BOX BEFORE HE REALIZED THEY WERE EXPIRED IN 2021 AND RESULTED IN HIM GETTING UTI AS HE DID USE THE BOX OF EXPIRED CATHETERS PRIOR TO HIS UTI. HE DID NOTE THE LUBRICANT WAS YELLOW-ISH LOOKING. I EXPLAINED TO HIM THE IMPORTANCE OF NOT USING EXPIRED CATHETERS, HE IS AWARE HE HAS TO PAY MORE ATTENTION TO THE DATES FROM NOW ON. HE CATHS 3-4 TIMES A DAY FOR RETENTION FROM SPINA BIFIDA. HE SAID THESE CATHETERS TYPICALLY WORK WELL FOR HIM OVERALL WHEN NOT EXPIRED. HE SAID HE REALIZED HE HAD A UTI AS HE WAS HAVING BURNING, LOWER BACK PAIN AND FREQUENCY. HE WENT TO GET HIS URINE TESTED AND HE DID HAVE AN ANTIBIOTIC PRESCRIBED BY HIS DOCTOR AND HE IS NOW ON DAY 3 OF A 10 DAY COURSE OF ANTIBIOTICS, NAME UNKNOWN. HE STILL HAS SOME OF THE FREQUENCY BUT GETTING BETTER ON ANTIBIOTIC COURSE.

  Patient problems: Urinary Tract Infection

  MAUDE report 15499739 ↗