MAUDE Adverse Event Report: HOLLISTER INCORPORATED CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH; CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH - FLAT BARRIER, LOCK 'N ROLL CLOSURE

Model Number	89301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an ostomate experienced skin irritation and redness under the hollister ostomy barrier due to effluent leakage.It was further reported that prescriptive powder was required to address the skin irritation and redness.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review conducted based on lot number provided and records found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported irritation under the ostomy barrier cannot be determined.

• Brand Name: CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH
• Common Device Name: CERAPLUS ONE-PIECE FLAT DRAINABLE POUCH - FLAT BARRIER, LOCK 'N ROLL CLOSURE
• 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: 24293138
• Report Number: 1119193-2026-00003
• Device Sequence Number: 21413659
• Product Code: EXB
• UDI-Device Identifier: 00610075087198
• UDI-Public: (01)00610075087198(17)300801(30)10(10)5H102
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 89301
• Device Lot Number: 5H102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2025
• 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: 64 YR
• Patient Sex: Female