GentleCathTM 508995Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455142637), received between Dec 21, 2023 and Dec 21, 2023 — classified as 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 16, 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.

• MalfunctionDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 64 YEAR OLD MALE PATIENT, USING THE SUBJECT CATHETER ABOUT A YEAR, 4 X A DAY DUE TO ENLARGED BLADDER/ BLADDER ATONY WITHOUT CONCERNS USING THIS PRODUCT. AT THE END OF (B)(6) 2023 FOR SECOND TIME HE NOTICED HIS CATHETERS HAD A DEFECT WHICH HE BELIEVES CAUSED HIM A UTI WHILE USING THEM. PATIENT CLAIMING, IN (B)(6) 2023 HE NOTICED WHEN HE WOULD ACTIVATE THE STERILE WATER "BIG CHUNKS" OF THE WHITE COATING (THE HYDROPHILIC COATING)" FLOATING AROUND IN THE SLEEVE. HE ALSO SAW THAT PARTS OF THE CATHETER WERE "MORE CLEAR" THAN NORMAL AS WELL, LIKE THE COATING WAS COMING OFF IN PIECES AFTER ACTIVATION. HE USED THE CATHETER AND HAD NO PAIN AT ALL WHILE USING IT BUT THEN SHORTLY AFTER THAT HE GOT A UTI AND HE THINKS THIS DEFECT IS WHY. HE HAD IRRITATION, BURNING FREQUENCY URGENCY BLADDER CRAMPING AND HAD TO GO TO MD AND DID GET URINE TESTING AND UTI DIAGNOSED. HE DID HAVE AN ANTIBIOTIC PRESCRIBED WHICH HELPED THIS SYMPTOM. HE DESCRIBED THE ISSUE OF THE CATHETER TO HIS MD AND HIS MD TOLD HIM NOT TO USE ANY WITH THE CONCERN. PRIOR TO THIS HE HAD USED THIS CATHETER AND NEVER SAW THIS OCCUR AFTER ACTIVATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 18380127 ↗