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

Model Number	70124-2-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history records review and sterilization documentation review was conducted based on the lot number provided and they were found to be complete and accurate.Device samples not provided.The root cause of the reported urinary tract infections could not be determined.Causation has not been established.This product is not sold in the united states.This product is similar to 72144 vapro catheter sold in the united states.
Event or Problem Description
It was reported that the end user experienced an increase in urinary tract infections (utis) over the past few months following the product update from the hollister vapro pocket to the hydrabalance version.Specifically, it was reported that the end user experienced a total of three utis within the past two months.It was further reported that the end user first noticed a change in the catheter product approximately three months ago, and the onset of utis began shortly thereafter, approximately 8 to 10 weeks ago.It was also reported that the end user has been performing intermittent catheterization for approximately 3.5 to 4 years and uses this sku of catheters in the morning and at bedtime.While it was reported that the end user has experienced utis in the past, the end user reported that the frequency appears to have increased in recent months.It was additionally reported that the end user has been intermittently treated with antibiotics, but the end user does not feel that the treatment has been effective.

• Brand Name: VAPRO POCKET
• 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: 22859924
• Report Number: 9616668-2025-00020
• Device Sequence Number: 20778213
• Product Code: GBM
• UDI-Device Identifier: 00610075093069
• UDI-Public: (01)00610075093069(17)270101(30)30(10)5A293(93)HX
• 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): 08/21/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 70124-2-30
• Device Catalogue Number: 70124-2-30
• Device Lot Number: 5A293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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