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Aurora Hydrocolloide Adhesive Sheath SP302Recalls & reported problems

C. R. Bard, Inc. · Aurora Condomcatheter Met Hydrocolloide Kleefzone · Class 1

Data updated Oct 16, 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 00801741071973), received between Nov 2, 2018 and Nov 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Device problems

  • Difficult to Remove1
  • Nonstandard Device1
  • Physical Resistance/Sticking1

Patient problems

  • No Consequences Or Impact To Patient1
  • 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.

  • MalfunctionNov 2, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE SHEATHS WERE VERY STICKY AND HARD TO REMOVE.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 8033286 ↗

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

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

Sources and updates

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