MAUDE Adverse Event Report: HOLLISTER INCORPORATED NEW IMAGE DRAINABLE POUCH; 2-PIECE DRAINABLE OSTOMY POUCH

Model Number	18003
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided, enabling a device history record (dhr) review, which was completed with no anomalies identified.However, the pouch was not returned; therefore, a device evaluation could not be conducted.A complaint history trend analysis was performed for similar complaints, and no adverse trends were observed.Based on the information available, 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 experienced effluent leakage when the lock n roll closure of the hollister new image drainable pouch unrolled.It was reported that the end user wears depends, which also covers the pouch, and the pouch has been opening, resulting in contents leaking out into the depends.It was further reported that the leakage into her depends on led to a urinary tract infection (uti), for which she required antibiotic treatment.

• Brand Name: NEW IMAGE DRAINABLE POUCH
• Common Device Name: 2-PIECE DRAINABLE OSTOMY POUCH
• 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: 23366856
• Report Number: 1119193-2025-00041
• Device Sequence Number: 18362658
• Product Code: EXB
• UDI-Device Identifier: 00610075113958
• UDI-Public: (01)00610075113958(17)300601(30)10(10)5F252
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/23/2025

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: 18003
• Device Catalogue Number: 18003
• Device Lot Number: 5F252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female