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Pop-On™ Self-Adhering Male External Catheter 32103Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741070495), received between Jul 9, 2018 and Jul 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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

  • Material Integrity Problem1
  • Nonstandard Device1

Patient problems

  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 9, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

    IT WAS REPORTED THAT DURING THE INVESTIGATION IT WAS NOTED THAT ALL 6 OF THE SAMPLES TESTED ABOVE THE SPECIFICATION FOR STRONG ADHESIVE.

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

    MAUDE report 7670716 ↗

Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices

All DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices →

Sources and updates

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