MAUDE Adverse Event Report: Hollister Incorporated New Image; 2-Piece Drainable Ostomy Pouch

Catalog Number	18004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user experienced skin irritation associated with use of hollister new image 2-piece drainable ostomy pouch.It was reported that the fabric material of product 18004 was perceived to be heavier, rubbed against the skin, caused redness in areas of contact, and was more difficult to empty.It was also reported that the user began wearing undergarments and using a belt to reduce contact between the pouch and the skin.It was reported that the user had a large hernia, a prolapsed stoma, and an increase in stoma size.It was reported that the user had been evaluated by a nurse and physician and was being treated with prescribed nystatin powder for a suspected yeast-related skin condition; however, the treatment reportedly did not improve the symptoms.It was also reported that the nurse believed the condition to be dermatitis.It was reported that the symptoms remained ongoing at the time of the report.It was also reported that medical intervention was required, including evaluation by healthcare professionals and treatment with prescribed nystatin powder.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted and no exceptions or discrepancies were identified.A trend analysis was performed and no adverse trends were identified.The device sample was not returned; therefore, a device evaluation could not be performed.Based on the available information, the root cause of the reported event could not be determined.

• Brand Name: New Image
• Common Device Name: 2-Piece Drainable Ostomy Pouch
• 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: 50451162
• Report Number: 1119193-2025-00053
• Device Sequence Number: 10281561
• Product Code: EXB
• UDI-Device Identifier: 00610075113965
• UDI-Public: (01)00610075113965(17)310401(30)10(10)6D092
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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
• Device Catalogue Number: 18004
• Device Lot Number: 6D092
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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