MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO; VAPRO NO TOUCH URETHRAL INTERMITTENT CATHETER

Model Number	72164
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user who was using the hollister vapro catheters had trouble inserting two of the catheters but was successful catheterizing with the third one.It was reported that several days later, he was rushed to hospital and was told by the doctor he had urosepsis due to catheter use.In addition, it was reported that there were no issues with the lubrication, but it was just technique being that this was the first time this end user had performed self-catheterisation.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed.Device history review conducted and no issues identified.Sterilization review conducted and all results were acceptable.Sample not yet returned for evlauation.The root cause of the reported urosepsis could not be determined.

• Brand Name: VAPRO
• Common Device Name: VAPRO NO TOUCH URETHRAL INTERMITTENT CATHETER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford road; rehins, county mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24400689
• Report Number: 9616668-2026-00002
• Device Sequence Number: 15889932
• Product Code: KOD
• UDI-Device Identifier: 00610075092659
• UDI-Public: (01)00610075092659(17)270801(30)30(10)5H183(93)X1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 72164
• Device Lot Number: 5H183
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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