Pop-On™ Self-Adhering Male External Catheter 32104Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741070501), received between Dec 9, 2019 and Dec 19, 2019 — classified as 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
- Physical Resistance/Sticking2
Patient problems
- Discomfort2
- No Consequences Or Impact To Patient1
- Tissue Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2019Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking
IT WAS REPORTED THAT THE MEC SHEATH WAS NOT ABLE TO BE ROLLED DOWN. PER EMAIL ATTACHED, THE MEC ADHERES TO THE PATIENT'S PENIS CAUSING DISCOMFORT UPON REMOVAL.
Patient problems: Discomfort
MAUDE report 9497568 ↗MalfunctionDec 9, 2019Nonstandard Device; Nonstandard Device; Physical Resistance/Sticking
IT WAS REPORTED THAT THE PRODUCT WAS UNABLE TO ROLL DOWN AND ADHERED TO ITSELF. WHEN THE MALE EXTERNAL CATHETER WAS ABLE TO ROLL ON TO THE PATIENT, IT STUCK TO THE SKIN AND CAUSED DISCOMFORT UPON REMOVAL.
Patient problems: Discomfort; No Consequences Or Impact To Patient; Tissue Damage
MAUDE report 9440706 ↗
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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