Self-Cath 50462 / 212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932999939), received between Feb 19, 2021 and Feb 19, 2021 — 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 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.

• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE INVOLVES A (B)(6) FEMALE END USER. ON (B)(6) 2020 AT ABOUT 10 P.M. SHE WENT TO THE REST ROOM TO PERFORM CATHETERIZATION AND IMMEDIATELY FELT PAIN AFTER TAKING CATHETER OUT. ABOUT 1 HOUR LATER SHE WENT TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH POSSIBLE GALL BLADDER ISSUES. SHE WAS ADMITTED TO THE HOSPITAL FOR A SURGICAL PROCEDURE. WHEN THE SURGERY WAS COMPLETED SHE WAS INFORMED THAT HER GALL BLADDER WAS FINE, THAT WHEN THEY MOVED THE GALL BLADDER TO SEE IF THERE WERE GALL STONES PRESENT IT WAS OBSERVED THAT HER BLADDER WAS PERFORATED. THE PERFORATION WAS TREATED AND THE PATIENT WAS PLACED ON A FOLEY CATHETER UNTIL (B)(6) 2020 WHEN IT WAS REMOVED. THE PHYSICIAN BELIEVED THE CAUSE OF THE BLADDER PERFORATION WAS CATHETERIZATION. THE PATIENT IS WELL WITH NO FURTHER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Perforation

  MAUDE report 11349632 ↗