MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER; 1-PIECE UROSTOMY POUCH, SOFT CONVEX, CERAPLUS

Model Number	8413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user who had been using the hollister premier ostomy product for years developed a pressure wound and became septic.It was further reported that he had been in and out of rehab and the hospital for quite some time.No further information is known.
Additional Manufacturer Narrative
The ostomy appliance was not returned; 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.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.Only the di portion of the udi information is known due to lack of lot number information.

• Brand Name: PREMIER
• Common Device Name: 1-PIECE UROSTOMY POUCH, 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: 22108526
• Report Number: 1119193-2025-00019
• Device Sequence Number: 20633541
• Product Code: EXB
• UDI-Device Identifier: 00610075064489
• UDI-Public: (01)00610075064489
• 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): 05/29/2025

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: 8413
• Device Catalogue Number: 8413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/29/2025
• 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 Age: 67 YR
• Patient Sex: Male