MAUDE Adverse Event Report: HOLLISTER, INC. NEW IMAGE; Catheter, Urethral

Model Number	18373
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was not provided, so a dhr was not able to be performed.The udi number is unknown, due to no known lot, so the di was entered.The sample is unavailable for evaluation.Root cause was unable to be established.This appears to be an isolated event.It is not known how or if the colostomy pouch leaking caused or contributed to the reported urinary tract infections.Hollister incorporated will continue to monitor this type of issue in our post-market surveillance system.
Event or Problem Description
It was reported that the last two boxes of hollister colostomy pouches that the end user received had pouches that were open as if they were "cut with a razor blade".It was further reported that the output leaked all over the end user and that he experienced multiple bladder infections from it.Additionally, it was reported that the end user was sick and hospitalized for the bladder infections.Despite multiple attempts, hollister was unable to obtain further event information.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
A visual inspection was performed, and it was confirmed that lubricate was present on the returned and the retention samples.No dry catheter condition was observed.A functional testing, and weight measurements on returned and control samples confirmed a less lubricated condition based on low weight.Testing confirmed a reduced lubrication condition, and the device was determined not to meet specifications.The investigation identified a likely manufacturing-related cause for the reduced lubrication condition.Pull force testing on retained samples met acceptance requirements, indicating insertion and withdrawal of the catheter would be expected to be successful.Review of the dhr confirmed the product was manufactured in accordance with validated processes and approved work instructions, and all reviewed records were acceptable causation between the hollister apogee catheter and the reported uti was unable to be established.

• Brand Name: NEW IMAGE
• Common Device Name: Catheter, Urethral
• Manufacturer (Section D): HOLLISTER, INC.; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER, INC.; 366 draft avenue; sturats draft IL 24477 -564
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville, IL 60048
• MDR Report Key: 24009603
• Report Number: 1119193-2026-00001
• Device Sequence Number: 9250101
• Product Code: GBM
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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?: Yes
• Device Model Number: 18373
• Device Catalogue Number: 18373
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Sex: Male