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Clear Advantage Male Continence Sheath 1363Recalls & reported problems

C. R. Bard, Inc. · Clear Advantage with Aloe Clear Silicone Self-Adhesive Male Continence Sheath · 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 00801741070327), received between Dec 21, 2018 and Dec 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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

  • Difficult to Fold, Unfold or Collapse1
  • Nonstandard Device1

Patient problems

  • Discomfort1

Recent adverse event reports

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

  • MalfunctionDec 21, 2018Nonstandard Device; Difficult to Fold, Unfold or Collapse; Nonstandard Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER WAS DIFFICULT TO UNROLL. THE PATIENT BELIEVES THERE WAS TOO MUCH ADHESIVE. THE PATIENT EXPERIENCED DISCOMFORT. NO MEDICAL INTERVENTION REPORTED.

    Patient problems: Discomfort

    MAUDE report 8189528 ↗

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

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Sources and updates

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