MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO POCKET

Model Number	70144-30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an end user received expired boxes of vapro pocket intermittent catheters.Prior to noticing the expiration date, the user utilized the products for self-catheterization.It was further reported that during use, some catheters were observed to have inadequate lubrication upon opening, with the issue becoming evident upon removal when the catheters snagged on the urethra.Subsequently, it was reported that the user developed a urinary tract infection.
Additional Manufacturer Narrative
The expiration date was clearly indicated on the product packaging; however, the end user did not adhere to this labeling and used the product beyond its shelf life.The manufacturer provides expiration dates and instructions for use to ensure product integrity and patient safety.Once a product is used beyond its labeled expiration date, the manufacturer cannot verify device performance or integrity.Due to the absence of traceability information, including the lot number and production identifiers, a device history record (dhr) review could not be performed.Consequently, only the device identifier (di) portion of the unique device identifier (udi) could be referenced.Based on the limited information available, a causal relationship between the use of the hollister catheter and the reported urinary tract infection (uti) cannot be established.

• Brand Name: VAPRO POCKET
• Common Device Name: VAPRO POCKET
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER ULC; foxford rd.; rehins; ballina, county mayo F26 F 3X5; EI F26 F3X5
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., IL 60048 ; 8479321271
• MDR Report Key: 23582072
• Report Number: 9616668-2025-00029
• Device Sequence Number: 9533156
• Product Code: GBM
• UDI-Device Identifier: 00610075067978
• UDI-Public: (01)00610075067978
• 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,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 70144-30
• Device Catalogue Number: 70144-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 50 YR
• Patient Sex: Male