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

Model Number	11704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Blister (4537)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The barrier was not saved; therefore, a device evaluation could not take place.A complaint history trend analysis was conducted for similar complaints and no adverse trends observed.A device history records (dhr) review could not be conducted because a lot number was not provided.Based on the information provided, a root cause of the event could not be determined.Hollister will continue to monitor this reported issue.Regarding udi information, only the di information is available.Since the lot number was not provided, the pi information is not available.
Event or Problem Description
It was reported that an end user who had previously used a skin protectant wipe beneath a hollister convex ostomy barrier was trailing a hollister soft convex ceraplus barrier without the skin protectant, during which blisters formed under the tape border.It was further reported that the blisters ruptured, prompting a visit to an urgent care facility where a medical professional prescribed a topical antibiotic ointment for the broken skin and provided samples of a steroid topical treatment for adjacent erythematous, non-broken skin.It was subsequently reported that the area is healing, and the user has resumed use of the original hollister convex ostomy barrier along with the skin protectant wipes.

• Brand Name: NEW IMAGE OSTOMY BARRIER
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, SOFT CONVEX, CERAPLUS
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 23293373
• Report Number: 1119193-2025-00040
• Device Sequence Number: 17342835
• Product Code: EXB
• UDI-Device Identifier: 00610075069095
• UDI-Public: (01)00610075069095
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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 Catalogue Number: 11704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 10/15/2025
• 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: Female