MAUDE Adverse Event Report: Hollister Incorporated Onli; Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper

Model Number	82164
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced urinary tract infections (utis) while using hollister's onli catherter.It was also reported that the catheter lubricant was thicker than normal and appeared gel-like rather than liquid and the patient associated the frequent utis with the thick lubricant.
Additional Manufacturer Narrative
A dhr review was conducted based on the lot number provided and the records were found to be complete and accurate.A review of production documentation, in-process and qai inspection records, gainseeker data, finished goods records, and sterilization documentation identified no abnormalities, non-conformances, or adverse trends related to the reported uti.A root cause could not be determined.Hollister will continue to monitor this reported issue.

• Brand Name: Onli
• Common Device Name: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• Manufacturer (Section D): Hollister Incorporated; 2000 hollister drive; libertyville IL 60048 -378
• Manufacturer (Section G): Hollister ULC; foxford road; rehins, ballina, county mayo F26 F 3X5,; GM F26 F3X5,
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50061124
• Report Number: 9616668-2026-00005
• Device Sequence Number: 9349828
• Product Code: GBM
• UDI-Device Identifier: 00610075072446
• UDI-Public: (01)00610075072446(17)270401(30)30(10)5D013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/28/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 82164
• Device Lot Number: 5D013
• 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: 07/16/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male