MAUDE Adverse Event Report: HOLLISTER INCORPORATED VAPRO PLUS

Model Number	7700144
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Urolithiasis (4861)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history records review and sterilization documentation review were not possible because the lot number was not provided.Device samples were not provided.A review of post-market surveillance data was conducted, and no additional reports were identified involving inadvertent insertion of the cap into the bladder.A review of the product's instructions for use (ifu) was conducted to assess adequacy.The ifu was found to be acceptable and provides sufficient guidance to support the safe and proper use of the device.The account was informed that the reported event reflects a use that is not aligned with the instructions for use (ifu).Udi pi information is not known since the lot number was not provided.
Event or Problem Description
It was reported that a patient who self-cathed at home or by a nurse inserted the hollister vapro intermittent catheter with the cap still on into the bladder, leading to the creation of a 4 cm bladder stone.In addition, it was reported that it also caused lower urinary tract symptoms worse than usual, resulting in repeated urinary tract infections.It was further reported that this ultimately required surgery under general anesthesia to remove the bladder stone, a ct scan, and a 3-day hospitalization.

• Brand Name: VAPRO PLUS
• Common Device Name: VAPRO PLUS
• 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: 22069610
• Report Number: 9616668-2025-00006
• Device Sequence Number: 13136935
• Product Code: GBM
• UDI-Device Identifier: 00610075061334
• UDI-Public: (01)00610075061334
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141642
• 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): 05/22/2025

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: 7700144
• Device Catalogue Number: 7700144
• Device Lot Number: UNKNOWN
• 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: 03/11/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown