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

Model Number	11704
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user developed irritation with weeping and blisters under the tape border of the hollister ostomy barrier 5 months after he first started using the product.It was further reported that despite using stoma powder and skin prep, the irritation continued.It was reported he went to see his health care professional who prescribed clobetasol cream to be used twice a week and the area is now improving.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review could not be conducted because lot number not provided.Sample not returned so sample evaluation not possible.Root cause of reported irritation under the ostomy tape border cannot be determined.Only the di is available for the udi since the lot number was not provided.

• Brand Name: HOLLISTER CERAPLUS OSTOMY BARRIER
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, SOFT CONVEX, 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: 24293140
• Report Number: 1119193-2026-00007
• Device Sequence Number: 10324516
• Product Code: EXB
• UDI-Device Identifier: 00610075069095
• UDI-Public: (01)00610075069095
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/09/2026

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: 11704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/09/2026
• 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 Sex: Male