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

Model Number	16103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Date of Event	04/15/2025
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 was conducted and the records were complete and accurate.There was no report of product malfunction.Based on the information provided, a root cause could not be determined.Hollister will continue to monitor this reported issue.
Event or Problem Description
It was reported that an end user who had been using the hollister new image ostomy barrier for over three years started experiencing skin inflammation and redness under the barrier over the last month.It was further reported that the end user tried steroid spray (triamcinolone spray) which seemed to help somewhat.

• Brand Name: NEW IMAGE
• Common Device Name: 2-PIECE OSTOMY SKIN BARRIER, FLEXTEND
• 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: 21949285
• Report Number: 1119193-2025-00015
• Device Sequence Number: 8691726
• Product Code: EXB
• UDI-Device Identifier: 00610075112920
• UDI-Public: (01)00610075112920(17)290601(30)5(10)4F052
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 16103
• Device Catalogue Number: 16103
• Device Lot Number: 4F052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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: 69 YR
• Patient Sex: Female