Self-Cath 50196 / 240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932575690), received between Jan 31, 2017 and May 10, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A FEMALE END-USER INFORMS THAT DURING THE LAST YEAR SHE HAS HAD 10 URINARY TRACT INFECTIONS (UTIS) AND 19 HOSPITAL STAYS DUE TO CATHETERISING. DURING THE LAST 30 YEARS SHE HAS HAD RECURRENT UTIS AND HOSPITALIZATION. THE END-USES STATES THAT IT IS NOT A PROBLEM WITH THE CATHETERS, THEY ARE NOT DEFECTIVE. THE END-USER ALSO INFORMS THAT SHE HAS BEEN HOSPITALIZED OVERNIGHT MANY TIMES OVER THE YEARS OF CATHETERIZING AND SHE HAS SEEN MANY DOCTORS ABOUT HOW TO STOP THE UTI'S FROM HAPPENING, BUT NO SOLUTION HAS BEEN FOUND YET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11802686 ↗
• InjuryJan 31, 2017Difficult to Remove; Device Handling Problem

  WAS THE USER HOSPITALIZED FOR MORE THAN 24 HRS/OVERNIGHT ADMISSION TO GET THE CATHETER SURGICALLY REMOVED? YES, SHE WAS IN THE HOSPITAL FOR ABOUT A DAY. BESIDES HAVING THE CATHETER STUCK WAS THE USER HARMED IN ANY WAY? PAIN, BLEEDING ETC.? SHE COULDN'T URINATE WHILE THE CATHETER WAS STUCK. WHAT WAS THE INDICATION FOR USE? NO SPECIFIC REASON TO USE 240, DIDN'T RECEIVE INSTRUCTION FROM HER PHYSICIAN, BUT RECEIVED A LITTLE INSTRUCTION. IS THE IT A FIRST TIME USER? SHE HAS BEEN CATHING FOR 15 YEARS, BUT HAS BEEN USING THE 240 FOR ABOUT A YEAR BUT HAS USED 214 PREVIOUSLY. WHAT IS THE OUTCOME? WAS IN THE HOSPITAL FOR A DAY AFTER HER SURGERY, THEN HAD A FOLEY CATHETER FOR ABOUT TWO WEEKS, AND WENT BACK TO INTERMITTENT CATHETERS. *EU IS A PARAPLEGIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6291042 ↗