Pop-On™ Self-Adhering Male External Catheter 32303Recalls & reported problems
C. R. Bard, Inc. · Pop-On™ Self-Adhering Male External Catheter · Class 1
All models of Pop-On Self-Adhering Male External Catheter (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741070563), received between Apr 2, 2020 and Mar 25, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Nonstandard 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
Device problems
- Nonstandard Device2
- Backflow1
- Biocompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- Skin Inflammation/ Irritation1
- Unspecified Infection1
- Urinary Tract Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER GOT STUCK ON AND IT WAS VERY HARD TO COME OFF WHICH CAUSED AN IRRITATION TO PATIENT'S SKIN. NO MEDICAL INTERVENTION REPORTED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 11569333 ↗MalfunctionDec 8, 2020Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT PATIENT SAID THAT MALE EXTERNAL CATHETER ORDER HAD TOO MUCH ADHESIVE IN THE LAST BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10972415 ↗InjuryApr 2, 2020Backflow; Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT ENDED UP WITH AN INFECTION DUE TO URINE THAT BACKED UP INTO THE MALE EXTERNAL CATHETER.
Patient problems: Unspecified Infection; Urinary Tract Infection
MAUDE report 9918357 ↗
Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices
- Spirit® Hydrocolloid Adhesive Sheath 39302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE48 reports
- Spirit® Hydrocolloid Adhesive Sheath 39303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE42 reports
- Spirit® Hydrocolloid Adhesive Sheath 35302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE36 reports
- Spirit® Hydrocolloid Adhesive Sheath 35303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE32 reports
- UltraFlex™ Self-Adhering Male External Catheter 33302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE31 reports
- Spirit® Hydrocolloid Adhesive Sheath 39304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Wideband™ Self-Adhering Male External Catheter 36302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Spirit® Hydrocolloid Adhesive Sheath 35304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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