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Wideband Male External Catheter 36303HPRecalls & reported problems

C. R. Bard, Inc. · Wideband Self-Adhering Male External Catheter · Class 1

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 00801741071072), received between May 26, 2021 and May 26, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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

  • Nonstandard Device1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

  • MalfunctionMay 26, 2021Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THERE WAS LOT OF GLUE ON THE MALE EXTERNAL CATHETER AND LEFT A LOT OF RESIDUES ON THE SKIN OF THE PENIS AFTER REMOVAL. STATED THAT IT CAUSED WOUNDS. NO MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11886992 ↗

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

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

Sources and updates

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