MAUDE Adverse Event Report: Hollister Incorporated VaPro Pocket; NoTouch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Ti

Model Number	70144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using a hollister vapro pocket intermittent catheter, the patient experienced difficulty inserting the catheter due to significant resistance, pain, irritation and possible injury resulting in discontinuation of catheterization.It was also reported that some catheters appeared bent, damaged, or broken within the packaging.It was also reported that the end user experienced utis.No further details regarding the reported issues were provided.
Additional Manufacturer Narrative
A device history record (dhr) and sterilization record review were completed and no adverse trends identified.All records reviewed were found to be complete and accurate, there were no adverse trends observed.Based on the information available at this time, a causal relationship between the device and the reported event has not been established.No root cause has been determined.

• Brand Name: VaPro Pocket
• Common Device Name: NoTouch Urethral Intermittent Catheter, Hydrophilic, Straight Tip, Protective Ti
• Manufacturer (Section D): Hollister Incorporated; 2000 hollister drive; libertyville IL 60048 -378
• 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: 50015473
• Report Number: 9616668-2026-00006
• Device Sequence Number: 21461235
• Product Code: GBM
• UDI-Device Identifier: 00610075093076
• UDI-Public: (01)00610075093076(17)2b0201(30)30(10)6B103(93)X3
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

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: 70144
• Device Lot Number: 6B103
• 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: 07/13/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2026
• 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