Clear Advantage Male Continence Sheath 786225Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741071720), received between Oct 27, 2021 and Sep 28, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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 18, 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.

• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER USED MALE EXTERNAL CATHETER FOR A LONG TIME. IT WAS STATED THAT THE PACKAGING OF THE PRODUCT HAD RECENTLY CHANGED, PREVIOUSLY WAS HARD PLASTIC BUT NOW THE PRODUCT COMES IN A SOFT FOAM TYPE PACKAGING, AND THEY DID NOT FEEL THEY WERE STERILE IN THIS NEW PACKAGING. ALSO, TWO OF THE MALE EXTERNAL CATHETERS IN THE BOX HAD HOLES IN, NOTICED THE MALE EXTERNAL HAD MATERIAL INSIDE AND NODULES ON THE OUTSIDE OF THE CATHETER WHICH USER FEELS HAD CAUSED INFECTIONS. THE USER EXTREMELY CONCERNED ABOUT THE PRODUCTS NOT BEING STERILE IN THE NEW PACKAGING AND PIECES OF MATERIAL FOUND IN THE PRODUCT. IT WAS NOTED THAT THE PATIENT REGULARLY EXPERIENCED INFECTIONS SINCE THE PRODUCT PACKAGING HAD CHANGED. IT WAS ALSO STATED THAT THE LEG BAGS, HAS HAD A FEW BAGS WHICH HAS HAD THE TUBE THAT CONNECT TO MALE EXTERNAL CATHETER BACK TO FRONT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17835169 ↗
• MalfunctionOct 27, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT USED THE MALE EXTERNAL CATHETER FOR A WHILE AND THERE HAD BEEN NO ISSUES UNTIL THAT BOX. THE PATIENT STATED THE SHEATHS WERE NOT STICKY AND HAD A POWDERY FEEL. IT WAS REPORTED THAT UPON SAMPLE INVESTIGATION, A STRONG ADHESIVE RESULT WAS FOUND FOR THE MALE EXTERNAL CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12706227 ↗