MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO; NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T

Model Number	72144-2-30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive review of the device history records was conducted.All documentation was found to be complete, accurate, and in compliance with applicable regulatory requirements.Sterilization records were examined and confirmed to be within the validated parameters established during the product's qualification and routine processing.Based on the available information, a definitive causal relationship between the use of the hollister catheter and the reported urinary tract infections (utis) could not be established.
Event or Problem Description
It was reported that some of the hollister vapro catheters were difficult to insert and remove and some of them got stuck in the urethra.It was reported that this has led to an increase in urinary tract infections.It was further reported that the user has been using the products for a long time and was very satisfied with the new coating, but for the past few months these problems have occurred.

• Brand Name: VAPRO
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER, HYDROPHILIC, STRAIGHT TIP, PROTECTIVE T
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, ; EI
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 23277436
• Report Number: 9616668-2025-00026
• Device Sequence Number: 5507421
• Product Code: GBM
• UDI-Device Identifier: 00610075092642
• UDI-Public: (01)00610075092642(17)270301(30)30(10)5C253(93)X2
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72144-2-30
• Device Catalogue Number: 72144-2-30
• Device Lot Number: 5C253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male