Pop-On™ Self-Adhering Male External Catheter 32301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741070525), received between Sep 16, 2019 and Sep 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2019Nonstandard Device; Defective Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT UNROLL PROPERLY. WHEN THEY WERE ATTACHED TO THE PENILE SHAFT, IT WAS A MATTER OF TIME UNTIL THEY CAME OFF AGAIN. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM IBC REPRESENTATIVE, THE COMPLAINANT DID NOT ALLEGED TOO MUCH ADHESIVE ON THE MEC. PER SAMPLE EVALUATION, THREE SAMPLES WERE TESTED FROM THE LOT SAMPLE AND WERE FOUND TO HAVE WEAK ADHESIVE.

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

  MAUDE report 9071124 ↗
• MalfunctionSep 16, 2019Nonstandard Device; Defective Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS DID NOT UNROLL PROPERLY. WHEN THEY WERE ATTACHED TO THE PENILE SHAFT, IT WAS A MATTER OF TIME UNTIL THEY CAME OFF AGAIN.

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

  MAUDE report 9071119 ↗