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

Model Number	11204
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review could not be conducted due to no lot number provided.Sample not returned so sample evaluation not possible.Root cause of reported leakage and irritation under the ostomy barrier cannot be definitively determined.Only the di for the udi is available due to lack of lot number information.
Event or Problem Description
It was reported that an end user had been using several hollister ostomy barriers a day after she lost 60 pounds and there was a lot of loose skin.It was further reported that she was experiencing barrier leakage on the bottom or left side and had irritation with fungal and yeast infections.It was additionally reported that she has been using prednisone cream per her doctor which is not allowing her barrier to adhere to the skin.Hollister provided suggestions to end user.

• Brand Name: NEW IMAGE BARRIER
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, CERAPLUS
• 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: 24367071
• Report Number: 1119193-2026-00011
• Device Sequence Number: 17446809
• Product Code: EXB
• UDI-Device Identifier: 00610075029853
• UDI-Public: (01)00610075029853
• 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): 02/17/2026

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: 11204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Female