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Clear Advantage Spirit Adhesive Sheath 5283Recalls & reported problems

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

All models of Clear Advantage Spirit Adhesive Sheath (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741071577), received between Nov 20, 2017 and Mar 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

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 Device2
  • Sticking1

Patient problems

  • Injury1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 4, 2022Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THE ADHESIVE ON HALF OF THE MALE EXTERNAL SHEATHS HAD SEEMED TO BE MELTED. THEY WERE STICKING TO INSIDE OF THE PACKETS WHICH MADE DIFFICULT TO TAKE THE SHEATHS OUT, BUT WHEN FITTED THEY WERE UNCOMFORTABLE TO THE PATIENT. THE SHEATHS ALSO LEFT BLACK ADHESIVE ON THE PENIS WHEN REMOVED AND CAUSED THE PATIENT TO GO THROUGH DOUBLE THEIR ADHESIVE REMOVER JUST TO GET THEM OFF. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA IBC ON 28-FEB-2022, THE PATIENT USED TWICE THE AMOUNT OF ADHESIVE REMOVER AND SO IT WAS MADE SURE THE PENIS WAS CLEAN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13666974 ↗
  • MalfunctionDec 15, 2020Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE ON THE TOP OF THE SHEATH WHEN COMPARED WITH THE REST OF THE SHEATHS. THE PATIENT ALSO REPORTED OF A DRAINING ISSUE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11006489 ↗
  • MalfunctionNov 20, 2017Sticking

    IT WAS REPORTED THAT THE PRODUCT HAD TOO MUCH ADHESIVE; THE ADHESIVE STUCK TO THE PATIENT'S HAIR AND PULLED ON IT MAKING THE PATIENT SORE.

    Patient problems: Injury

    MAUDE report 7046665 ↗

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

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

Sources and updates

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