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Aurora Hydrocolloide Adhesive Sheath SW301Recalls & reported problems

C. R. Bard, Inc. · Aurora Condomcatheter Met Hydrocolloide Kleefzone · 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 00801741072062), received between Oct 28, 2020 and Oct 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

  • Nonstandard Device1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • MalfunctionOct 28, 2020Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT CONDOM CATHETERS AS A TRIAL INDICATED ON STYLE 3 WAS ALMOST UNREMOVABLE. PATIENT TRIED AT LEAST 10 MIN IN THE SHOWER TO ROLL OFF THE CONDOM, WITH HOT SOAP AND WATER WHICH WAS VERY PAINFUL WITH WOUNDS ON THE PENIS, ALSO A LOT OF STICKY MATERIAL REMAINED. ALSO THE STYLE 1 GAVE THE SAMPLE PROBLEMS BE IT TO A SLIGHTLY LESSER EXTENT.

    Patient problems: No Code Available

    MAUDE report 10748097 ↗

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

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

Sources and updates

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