MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS POCKET; NO TOUCH URETHRAL INTERMITTENT CATHETER WITH INTEGRATED COLLECTION BAG, HYDROPHI

Model Number	71124-2-30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Hematuria (2558)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive review of the device history records was completed.All documentation was verified as complete, accurate, and compliant with applicable regulatory requirements.All manufacturing process steps were properly followed.Sterilization records were reviewed and confirmed to be within the validated parameters established during product qualification and routine processing.Based on the available information, a definitive causal relationship between the reported urinary tract infections and the hollister urinary catheters could not be established.Regarding the reported urethral bleeding, clinical factors such as patient technique, frequency of catheterization, and underlying medical conditions may contribute to such events.The report of three catheters being dry could not be independently confirmed.
Event or Problem Description
It was reported that an end user experienced heavy bleeding after using hollister vapro catheters.It was further reported that three catheters lacked lubrication.It was additionally reported that the end user was hospitalized and diagnosed with a urinary tract infection, requiring a 14-day course of antibiotics.It was also reported that the urethra was irritated with significant bleeding; however, the patient refused placement of an indwelling catheter and consequently must perform self-catheterization every hour.

• Brand Name: VAPRO PLUS POCKET
• Common Device Name: NO TOUCH URETHRAL INTERMITTENT CATHETER WITH INTEGRATED COLLECTION BAG, HYDROPHI
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048 3781
• Manufacturer (Section G): HOLLISTER LIETUVA UAB; oro parko str. 2, sergeicikai; karmelavos; kauno raj., ltu LT-54 462; LH LT-54462
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 23604047
• Report Number: 3016675012-2025-00014
• Device Sequence Number: 18602135
• Product Code: GBM
• UDI-Device Identifier: 00610075094462
• UDI-Public: (01)00610075094462(17)270901(30)30(10)5I059
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 71124-2-30
• Device Catalogue Number: 71124-2-30
• Device Lot Number: 5I059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male