MAUDE Adverse Event Report: Hollister Incorporated New Image; 2-Piece Ostomy Skin Barrier, Soft Convex, CeraPlus

Catalog Number	11704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: New Image
• Common Device Name: 2-Piece Ostomy Skin Barrier, Soft Convex, CeraPlus
• Manufacturer (Section D): Hollister Incorporated; 2000 hollister drive; libertyville IL 60048 -378
• Manufacturer (Section G): Hollister Incoporated; 366 draft avenue; stuarts draft VA 24477 -999
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50251750
• Report Number: 1119193-2026-00051
• Device Sequence Number: 9945002
• Product Code: EXB
• UDI-Device Identifier: 00610075069095
• UDI-Public: (01)00610075069095(17)310401(30)6(10)6D132
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Catalogue Number: 11704
• Device Lot Number: 6D132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2026
• 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