Pop-On™ Self-Adhering Male External Catheter 32302Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741070549), received between Aug 25, 2017 and Mar 20, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE MADE IT DIFFICULT TO APPLY AND REMOVE THE MALE EXTERNAL CATHETER . THE PATIENT¿S HAIR GOT CAUGHT IN THE ADHESIVE CAUSING PAIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16578477 ↗
• InjuryJun 21, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER PULL THE SKIN OFF OF THE PATIENT PENIS. DOCTOR TOLD THE PATIENT THAT THE CATHETER WAS TOO STICKY AND WAS CAUSING SORES, A RASH AND THE SKIN TO TEAR. PATIENT HAD HEALED SINCE THEY WERE NOT USING. PATIENT HAD BEEN WEARING DIAPERS. PATIENT HAD NURSE COMING TO HOME AND WAS PROVIDED SKIN PREPPING SPRAY.

  Patient problems: Rash; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 14757720 ↗
• MalfunctionMay 13, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE PRODUCT EXPIRATION DATE DIFFERED FROM THE BEST-BEFORE DATE ON THE CARTON/LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397626 ↗
• MalfunctionApr 12, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY USING MALE EXTERNAL CATHETER WITH ADHESIVE. STATED THAT SOME CATHETERS WERE STUCK CLOSED AND ADHESIVE IN SOME CATHETERS WERE TOO AGGRESSIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14086753 ↗
• MalfunctionAug 14, 2020Nonstandard Device; Difficult to Remove; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS TOO STICKY AND DIFFICULT TO REMOVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407696 ↗
• MalfunctionMar 21, 2020Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS EXTREMELY HARD TO COME OFF. THE PATIENT HAD REPORTEDLY TRIED A WARM CLOTH AND HOT SHOWER AS ADVISED WITH NO REMEDY. THE PATIENT STATED THE LAST CATHETER HE USED, HE HAD TO REMOVE IT WITH A PAIR OF SCISSORS.

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

  MAUDE report 9863583 ↗
• InjuryDec 20, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEC SHEATHS CAUSED THE USER TO HAVE A SKIN REACTION. ONCE HEALED THE PATIENT TRIED THE PRODUCT AGAIN, WHICH RESULTED IN A MORE SEVERE REACTION OF REDNESS, SORENESS, BLISTERS AND PEELING SKIN. THE GENERAL PRACTITIONER ADVISED HIM TO DISCONTINUE USE.

  Patient problems: Reaction; Skin Irritation; Swelling

  MAUDE report 9507809 ↗
• MalfunctionApr 24, 2019Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE ADHESIVE WAS TOO THICK. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8547197 ↗
• InjuryMar 11, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC SKIN REACTION ON HIS PENIS. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL (B)(6)2019 ; AFTER USE OF THE MEC SHEATHS, THE PATIENT NOTICED A BURNING SENSATION ON THE PENILE SKIN, CAUSING SWELLING AND REDNESS. THIS LATER TURNED INTO RED AND SPOTTY BUBBLES. THE PATIENT VISITED THE UROLOGIST AND WAS TESTED FOR A FUNGAL INFECTION, WHICH WAS NEGATIVE. THE DOCTOR PRESCRIBED AN ANTI-FUNGAL OINTMENT AND RECOMMENDED CHAMOMILE BATHS TO CLEAR THE RASH REACTION. THE PATIENT HAS SINCE DISCONTINUED USE OF THE MEC SHEATHS. THE PATIENT USED THE SHEATHS FOR 7 MONTHS BEFORE PRIOR TO THIS EVENT. PER ADDITIONAL INFORMATION FROM THE IBC VIA EMAIL(B)(6)2019 ; AS OF(B)(6)2019 THE PATIENTS SKIN HAS HEALED AND THE PATIENT HAS RESUMED USING THE MEC SHEATHS WITH NO ISSUES.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Rash; Reaction; Swelling

  MAUDE report 8410118 ↗
• MalfunctionAug 25, 2017Difficult to Remove; Sticking

  IT WAS REPORTED THAT THERE WAS TOO MUCH ADHESIVE ON THE MALE EXTERNAL CATHETER MAKING IT HARD TO REMOVE, SO MUCH SO IT STICKS TO THE SKIN AND SOMETIMES CAUSES DAMAGE. IT WAS NOTED THAT THE TYPE OF SKIN DAMAGE IS UNKNOWN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Tissue Damage

  MAUDE report 6820051 ↗