MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE BARRIER; 2-PIECE OSTOMY SKIN BARRIER

Model Number	14602
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user's hollister new image barrier was only adhering 1-3 days leading to leakage, skin irritation and pain.It was reported he went to the hospital for the rash and pain, and they prescribed a 5-day course of high dose ibuprofen.It was further reported that over time, the wear time and skin irritation has not improved and so now he is on an antibiotic ointment for the skin.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review conducted and the records were complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported leakage and irritation under the ostomy barrier cannot be definitively determined.

• Brand Name: NEW IMAGE BARRIER
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24429570
• Report Number: 1119193-2026-00013
• Device Sequence Number: 21408516
• Product Code: EXB
• UDI-Device Identifier: 00610075146024
• UDI-Public: (01)00610075146024(17)300901(30)5(10)5I252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 14602
• Device Lot Number: 5I252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male