MAUDE Adverse Event Report: HOLLISTER INCORPORATED CERAPLUS BARRIER RING; OSTOMY BARRIER RING

Model Number	8815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/23/2026
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 lack of lot number information.Sample not returned so sample evaluation not possible.Root cause of reported irritation under the ostomy barrier ring cannot be determined.Only the di information of the udi is known due to lack of lot number information.
Event or Problem Description
It was reported that an end user using the hollister ceraplus slim fit barrier ring experienced irritated skin and the nurse had to use nystatin.It was further reported that the ring was applied after the operation and thinks they used the ring twice and no longer using the product.

• Brand Name: CERAPLUS BARRIER RING
• Common Device Name: OSTOMY BARRIER RING
• 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: 24305613
• Report Number: 1119193-2026-00009
• Device Sequence Number: 18554739
• Product Code: EXB
• UDI-Device Identifier: 00610075059720
• UDI-Public: (01)00610075059720
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/10/2026

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: 8815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/10/2026
• 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: 61 YR
• Patient Sex: Male