UltraFlex™ Self-Adhering Male External Catheter 33304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741070792), received between May 27, 2020 and Jul 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2020Nonstandard Device; Nonstandard Device; Product Quality Problem

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD ADHESIVE INSIDE AND OUTSIDE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10224236 ↗
• MalfunctionJun 5, 2020Nonstandard Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE FOUND DEFECTIVE AND HAD ADHESION ALL OVER THEM. TWO PRODUCTS WERE ALLEGED 33304 AND 33305.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10122449 ↗
• MalfunctionMay 27, 2020Nonstandard Device; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE EXTERNALS LEFT A RESIDUE BEHIND WHEN REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10091596 ↗