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

Catalog Number	82124
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hollister onli hydrophilic intermittent catheter was difficult to insert due to a protrusion in the middle of the catheter.It was reported that during removal of the catheter from the urethra, it caused a urethral injury and then he experienced a bladder infection.
Additional Manufacturer Narrative
The lot number was not available; therefore, a device history record (dhr) review could not be performed.Trend analysis was performed and no adverse trend was identified.Based on the information available, no root cause could be determined.Only the device identifier (di) portion of the udi was available.

• Brand Name: Onli
• Common Device Name: Hydrophilic Urethral Intermittent Catheter, Straight; with Gripper
• Manufacturer (Section D): Hollister Incoporated; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): Hollister ULC; foxford road; rehins, ballina, county mayo F26 F 3X5,; EI F26 F3X5,
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50817741
• Report Number: 9616668-2026-00009
• Device Sequence Number: 18819634
• Product Code: GBM
• UDI-Device Identifier: 00610075072422
• UDI-Public: (01)00610075072422
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2026

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 Catalogue Number: 82124
• Device Lot Number: Unknown
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• 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 Sex: Male