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	09/24/2025
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 an end user who had been using the hollister vapro catheters for the past 15 years experienced severe urethral irritation after some catheters from the pack could not be inserted properly.It was reported that the catheter would not slide in the urethra.It was further reported that he visited the urologist where he had a bacterial culture done and was diagnosed with a uti.

• 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: 23334974
• Report Number: 9616668-2025-00027
• Device Sequence Number: 10612526
• Product Code: GBM
• UDI-Device Identifier: 00610075092642
• UDI-Public: (01)00610075092642(17)270201(30)30(10)5B153(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: 5B153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2025
• 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