InView Standard 97541Recalls & reported problems
Hollister Incorporated · Male Incontinence Catheter, Self-Adhesive · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075975419), received between Feb 3, 2025 and Feb 3, 2025 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Contact Dermatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT FOR THE LAST 6 WEEKS THE END USER'S WIFE SAID THE HOLLISTER INVIEW MALE EXTERNAL CATHETER FELT LIKE DIFFERENT MATERIAL. IT WAS REPORTED THAT THEY WERE NOT FLAT BUT WERE FLUTED AND WERE NOT STICKING AT ALL. IT WAS FURTHER REPORTED THAT CAUSED LEAKAGE OF URINE WHICH BURNED THE SKIN. ADDITIONALLY, IT WAS REPORTED THAT THEY SOUGHT MEDICAL HELP, THAT THE NURSE PRESCRIBED STEROID CREAM AND WILL CONTINUE TO MONITOR THE END USER REGULARLY.
Patient problems: Contact Dermatitis
MAUDE report 21292367 ↗
Other DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE devices
- Spirit® Hydrocolloid Adhesive Sheath 39302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE48 reports
- Spirit® Hydrocolloid Adhesive Sheath 39303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE42 reports
- Spirit® Hydrocolloid Adhesive Sheath 35302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE36 reports
- Spirit® Hydrocolloid Adhesive Sheath 35303C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE32 reports
- UltraFlex™ Self-Adhering Male External Catheter 33302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE31 reports
- Wideband™ Self-Adhering Male External Catheter 36302C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Spirit® Hydrocolloid Adhesive Sheath 39304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE29 reports
- Spirit® Hydrocolloid Adhesive Sheath 35304C. R. Bard, Inc. · DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page