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Wideband™ Self-Adhering Male External Catheter 36105Recalls & reported problems

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

All models of Wideband 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 00801741071010), received between Jul 7, 2017 and Jul 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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

  • Device Misassembled During Manufacturing /Shipping1
  • Difficult to Remove1
  • Sticking1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 7, 2017Difficult to Remove; Sticking; Device Misassembled During Manufacturing /Shipping

    IT WAS REPORTED THAT THE ADHESIVE WAS STRONG, AS A RESULT IT ALLEGEDLY TOOK 45 MINUTES TO REMOVE THE MALE EXTERNAL CATHETER FROM THE PATIENT'S SKIN. NO MEDICAL INTERVENTION WAS REQUIRED AND NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6695699 ↗

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

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Sources and updates

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