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Spirit® Hydrocolloid Adhesive Sheath 39101Recalls & reported problems

C. R. Bard, Inc. · Spirit® Hydrocolloid Adhesive Sheath · Class 1

All models of Spirit Hydrocolloid Adhesive Sheath (28)

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 00801741071270), received between Sep 28, 2020 and Sep 28, 2020 — 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

  • Adverse Event Without Identified Device or Use Problem1
  • Nonstandard Device1

Patient problems

  • Laceration(s)1

Recent adverse event reports

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

  • MalfunctionSep 28, 2020Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN LACERATION DURING THE REMOVAL OF THE MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION REPORTED.

    Patient problems: Laceration(s)

    MAUDE report 10593497 ↗

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

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

Sources and updates

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