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	Difficult to Insert (1316)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	04/14/2025
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.Complaint data review was conducted and no adverse trends observed.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 70124 vapro catheter sold in the united states.
Event or Problem Description
It was reported that an end user who had been using the vapro pocket intermittent urethral catheter for 1 year received the vapro hydrabalance product and had been using it for 2 days when he found it difficult to insert and experienced stinging on withdrawal.It was further reported that he adjusted his catheterization technique, and the issue resolved.It was then reported that he developed a uti and with that there was some discomfort.Additionally, it was reported that he started antibiotics.

• 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: 21992835
• Report Number: 9616668-2025-00004
• Device Sequence Number: 12899860
• Product Code: GBM
• UDI-Device Identifier: 00610075093069
• UDI-Public: (01)00610075093069(17)270101(30)30(10)5A113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180824
• 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): 05/09/2025

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: 5A113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2025
• 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